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1.  In Vitro Fertilization and Multiple Pregnancies 
Executive Summary
Objective
The objective of this health technology policy assessment was to determine the clinical effectiveness and cost-effectiveness of IVF for infertility treatment, as well as the role of IVF in reducing the rate of multiple pregnancies.
Clinical Need: Target Population and Condition
Typically defined as a failure to conceive after a year of regular unprotected intercourse, infertility affects 8% to 16% of reproductive age couples. The condition can be caused by disruptions at various steps of the reproductive process. Major causes of infertility include abnormalities of sperm, tubal obstruction, endometriosis, ovulatory disorder, and idiopathic infertility. Depending on the cause and patient characteristics, management options range from pharmacologic treatment to more advanced techniques referred to as assisted reproductive technologies (ART). ART include IVF and IVF-related procedures such as intra-cytoplasmic sperm injection (ICSI) and, according to some definitions, intra-uterine insemination (IUI), also known as artificial insemination. Almost invariably, an initial step in ART is controlled ovarian stimulation (COS), which leads to a significantly higher rate of multiple pregnancies after ART compared with that following natural conception. Multiple pregnancies are associated with a broad range of negative consequences for both mother and fetuses. Maternal complications include increased risk of pregnancy-induced hypertension, pre-eclampsia, polyhydramnios, gestational diabetes, fetal malpresentation requiring Caesarean section, postpartum haemorrhage, and postpartum depression. Babies from multiple pregnancies are at a significantly higher risk of early death, prematurity, and low birth weight, as well as mental and physical disabilities related to prematurity. Increased maternal and fetal morbidity leads to higher perinatal and neonatal costs of multiple pregnancies, as well as subsequent lifelong costs due to disabilities and an increased need for medical and social support.
The Technology Being Reviewed
IVF was first developed as a method to overcome bilateral Fallopian tube obstruction. The procedure includes several steps: (1) the woman’s egg is retrieved from the ovaries; (2) exposed to sperm outside the body and fertilized; (3) the embryo(s) is cultured for 3 to 5 days; and (4) is transferred back to the uterus. IFV is considered to be one of the most effective treatments for infertility today. According to data from the Canadian Assisted Reproductive Technology Registry, the average live birth rate after IVF in Canada is around 30%, but there is considerable variation in the age of the mother and primary cause of infertility.
An important advantage of IVF is that it allows for the control of the number of embryos transferred. An elective single embryo transfer in IVF cycles adopted in many European countries was shown to significantly reduce the risk of multiple pregnancies while maintaining acceptable birth rates. However, when number of embryos transferred is not limited, the rate of IVF-associated multiple pregnancies is similar to that of other treatments involving ovarian stimulation. The practice of multiple embryo transfer in IVF is often the result of pressures to increase success rates due to the high costs of the procedure. The average rate of multiple pregnancies resulting from IVF in Canada is currently around 30%.
An alternative to IVF is IUI. In spite of reported lower success rates of IUI (pregnancy rates per cycle range from 8.7% to 17.1%) it is generally attempted before IVF due to its lower invasiveness and cost.
Two major drawbacks of IUI are that it cannot be used in cases of bilateral tubal obstruction and it does not allow much control over the risk of multiple pregnancies compared with IVF. The rate of multiple pregnancies after IUI with COS is estimated to be about 21% to 29%.
Ontario Health Insurance Plan Coverage
Currently, the Ontario Health Insurance Plan covers the cost of IVF for women with bilaterally blocked Fallopian tubes only, in which case it is funded for 3 cycles, excluding the cost of drugs. The cost of IUI is covered except for preparation of the sperm and drugs used for COS.
Diffusion of Technology
According to Canadian Assisted Reproductive Technology Registry data, in 2004 there were 25 infertility clinics across Canada offering IVF and 7,619 IVF cycles performed. In Ontario, there are 13 infertility clinics with about 4,300 IVF cycles performed annually.
Literature Review
Royal Commission Report on Reproductive Technologies
The 1993 release of the Royal Commission report on reproductive technologies, Proceed With Care, resulted in the withdrawal of most IVF funding in Ontario, where prior to 1994 IVF was fully funded. Recommendations of the Commission to withdraw IVF funding were largely based on findings of the systematic review of randomized controlled trials (RCTs) published before 1990. The review showed IVF effectiveness only in cases of bilateral tubal obstruction. As for nontubal causes of infertility, there was not enough evidence to establish whether IVF was effective or not.
Since the field of reproductive technology is constantly evolving, there have been several changes since the publication of the Royal Commission report. These changes include: increased success rates of IVF; introduction of ICSI in the early 1990’s as a treatment for male factor infertility; and improved embryo implantation rates allowing for the transfer of a single embryo to avoid multiple pregnancies after IVF.
Studies After the Royal Commission Report: Review Strategy
Three separate literature reviews were conducted in the following areas: clinical effectiveness of IVF, cost-effectiveness of IVF, and outcomes of single embryo transfer (SET) in IVF cycles.
Clinical effectiveness of IVF: RCTs or meta-analyses of RCTs that compared live birth rates after IVF versus alternative treatments, where the cause of infertility was clearly stated or it was possible to stratify the outcome by the cause of infertility.
Cost effectiveness of IVF: All relevant economic studies comparing IVF to alternative methods of treatment were reviewed
Outcomes of IVF with SET: RCTs or meta-analyses of RCTs that compared live birth rates and multiple birth rates associated with transfer of single versus double embryos.
OVID MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Cochrane Library, the International Agency for Health Technology Assessment database, and websites of other health technology assessment agencies were searched using specific subject headings and keywords to identify relevant studies.
Summary of Findings
Comparative Clinical Effectiveness of IVF
Overall, there is a lack of well composed RCTs in this area and considerable diversity in both definition and measurement of outcomes exists between trials. Many studies used fertility or pregnancy rates instead of live birth rates. Moreover, the denominator for rate calculation varied from study to study (e.g. rates were calculated per cycle started, per cycle completed, per couple, etc...).
Nevertheless, few studies of sufficient quality were identified and categorized by the cause of infertility and existing alternatives to IVF. The following are the key findings:
A 2005 meta-analysis demonstrated that, in patients with idiopathic infertility, IVF was clearly superior to expectant management, but there were no statistically significant differences in live birth rates between IVF and IUI, nor between IVF and gamete-intra-Fallopian transfer.
A subset of data from a 2000 study showed no significant differences in pregnancy rates between IVF and IUI for moderate male factor infertility.
In patients with moderate male factor infertility, standard IVF was also compared with ICSI in a 2002 meta-analysis. All studies included in the meta-analysis showed superior fertilization rates with ICSI, and the pooled risk ratio for oocyte fertilization was 1.9 (95% Confidence Interval 1.4-2.5) in favour of ICSI. Two other RCTs in this area published after the 2002 meta-analysis had similar results and further confirmed these findings. There were no RCTs comparing IVF with ICSI in patients with severe male factor infertility, mainly because based on the expert opinion, ICSI might only be an effective treatment for severe male factor infertility.
Cost-Effectiveness of IVF
Five economic evaluations of IVF were found, including one comprehensive systematic review of 57 health economic studies. The studies compared cost-effectiveness of IVF with a number of alternatives such as observation, ovarian stimulation, IUI, tubal surgery, varicocelectomy, etc... The cost-effectiveness of IVF was analyzed separately for different types of infertility. Most of the reviewed studies concluded that due to the high cost, IVF has a less favourable cost-effectiveness profile compared with alternative treatment options. Therefore, IVF was not recommended as the first line of treatment in the majority of cases. The only two exceptions were bilateral tubal obstruction and severe male factor infertility, where an immediate offer of IVF/ICSI might the most cost-effective option.
Clinical Outcomes After Single Versus Double Embryo Transfer Strategies of IVF
Since the SET strategy has been more widely adopted in Europe, all RCT outcomes of SET were conducted in European countries. The major study in this area was a large 2005 meta-analysis, followed by two other published RCTs.
All of these studies reached similar conclusions:
Although a single SET cycle results in lower birth rates than a single double embryo transfer (DET) cycle, the cumulative birth rate after 2 cycles of SET (fresh + frozen-thawed embryos) was comparable to the birth rate after a single DET cycle (~40%).
SET was associated with a significant reduction in multiple births compared with DET (0.8% vs. 33.1% respectively in the largest RCT).
Most trials on SET included women younger than 36 years old with a sufficient number of embryos available for transfer that allowed for selection of the top quality embryo(s). A 2006 RCT, however, compared SET and DET strategies in an unselected group of patients without restrictions on the woman’s age or embryo quality. This study demonstrated that SET could be applied to older women.
Estimate of the Target Population
Based on results of the literature review and consultations with experts, four categories of infertile patients who may benefit from increased access to IVF/ICSI were identified:
Patients with severe male factor infertility, where IVF should be offered in conjunction with ICSI;
Infertile women with serious medical contraindications to multiple pregnancy, who should be offered IVF-SET;
Infertile patients who want to avoid the risk of multiple pregnancy and thus opt for IVF-SET; and
Patients who failed treatment with IUI and wish to try IVF.
Since, however, the latter indication does not reflect any new advances in IVF technology that would alter existing policy, it was not considered in this analysis.
Economic Analysis
Economic Review: Cost–Effectiveness of SET Versus DET
Conclusions of published studies on cost-effectiveness of SET versus DET were not consistent. While some studies found that SET strategy is more cost-effective due to avoidance of multiple pregnancies, other studies either did not find any significant differences in cost per birth between SET and DET, or favoured DET as a more cost-effective option.
Ontario-Based Economic Analysis
An Ontario-based economic analysis compared cost per birth using three treatment strategies: IUI, IVF-SET, and IVF-DET. A decision-tree model assumed three cycles for each treatment option. Two separate models were considered; the first included only fresh cycles of IVF, while the second had a combination of fresh and frozen cycles. Even after accounting for cost-savings due to avoidance of multiple pregnancies (only short-term complications), IVF-SET was still associated with a highest cost per birth. The approximate budget impact to cover the first three indications for IVF listed above (severe male factor infertility, women with medical contraindications to multiple pregnancy, and couples who wish to avoid the risk of multiple pregnancy) is estimated at $9.8 to $12.8 million (Cdn). Coverage of only first two indications, namely, ICSI in patients with severe male factor infertility and infertile women with serious medical contraindications to multiple pregnancy, is estimated at $3.8 to $5.5 million Cdn.
Other Considerations
International data shows that both IVF utilization and the average number of embryos transferred in IVF cycles are influenced by IVF funding policy. The success of the SET strategy in European countries is largely due to the fact that IVF treatment is subsidized by governments.
Surveys of patients with infertility demonstrated that a significant proportion (~40%) of patients not only do not mind having multiple babies, but consider twins being an ideal outcome of infertility treatment.
A women’s age may impose some restrictions on the implementation of a SET strategy.
Conclusions and Recommendations
A review of published studies has demonstrated that IVF-SET is an effective treatment for infertility that avoids multiple pregnancies.
However, results of an Ontario-based economic analysis shows that cost savings associated with a reduction in multiple pregnancies after IVF-SET does not justify the cost of universal IVF-SET coverage by the province. Moreover, the province currently funds IUI, which has been shown to be as effective as IVF for certain types of infertility and is significantly less expensive.
In patients with severe male factor infertility, IVF in conjunction with ICSI may be the only effective treatment.
Thus, 2 indications where additional IVF access should be considered include:
IVF/ICSI for patients with severe male factor infertility
IVF-SET in infertile women with serious medical contraindications to multiple pregnancy
PMCID: PMC3379537  PMID: 23074488
2.  Article processing charges, funding, and open access publishing at Journal of Experimental & Clinical Assisted Reproduction 
Journal of Experimental & Clinical Assisted Reproduction is an Open Access, online, electronic journal published by BioMed Central with full contents available to the scientific and medical community free of charge to all readers. Authors maintain the copyright to their own work, a policy facilitating dissemination of data to the widest possible audience without requiring permission from the publisher. This Open Access publishing model is subsidized by authors (or their institutions/funding agencies) in the form of a single £330 article processing charge (APC), due at the time of manuscript acceptance for publication. Payment of the APC is not a condition for formal peer review and does not apply to articles rejected after review. Additionally, this fee is waived for authors whose institutions are BioMed Central members or where genuine financial hardship exists. Considering ordinary publication fees related to page charges and reprints, the APC at Journal of Experimental & Clinical Assisted Reproduction is comparable to costs associated with publishing in some traditional print journals, and is less expensive than many. Implementation of the APC within this Open Access framework is envisioned as a modern research-friendly policy that supports networking among investigators, brings new research into reach rapidly, and empowers authors with greater control over their own scholarly publications.
doi:10.1186/1743-1050-2-1
PMCID: PMC546227  PMID: 15649322
3.  Factors Affecting Journal Quality Indicator in Scopus (SCImago Journal Rank) in Obstetrics and Gynecology Journals: a Longitudinal Study (1999-2013) 
Acta Informatica Medica  2014;22(6):385-388.
Introduction:
Awareness of the latest scientific research and publishing articles in top journals is one of the major concerns of health researchers. In this study, we first introduced top journals of obstetrics and gynecology field based on their Impact Factor (IF), Eigenfactor Score (ES) and SCImago Journal Rank (SJR) indicator indexed in Scopus databases and then the scientometric features of longitudinal changes of SJR in this field were presented.
Method and material:
In our analytical and bibiliometric study, we included all the journals of obstetrics and gynecology field which were indexed by Scopus from 1999 to 2013. The scientometric features in Scopus were derived from SCImago Institute and IF and ES were obtained from Journal Citation Report through the Institute for Scientific Information. Generalized Estimating Equation was used to assess the scientometric features affecting SJR.
Result:
From 256 journals reviewed, 54.2% and 41.8% were indexed in the Pubmed and the Web of Sciences, respectively. Human Reproduction Update based on the IF (5.924±2.542) and SJR (2.682±1.185), and American Journal of obstetrics and gynecology based on the ES (0.05685±0.00633) obtained the first rank among the other journals. Time, Index in Pubmed, H_index, Citable per Document, Cites per Document, and IF affected changes of SJR in the period of study.
Discussion:
Our study showed a significant association between SJR and scientometric features in obstetrics and gynecology journals. According to this relationship, SJR may be an appropriate index for assessing journal quality.
doi:10.5455/aim.2014.22.385-388
PMCID: PMC4315645
Journal quality; obstetrics and gynecology; Impact Factor; Eigenfactor Score; SCImago Journal Rank
4.  Creating a Three-Parent Child: An Educational Paradigm for the Responsible Conduct of Research 
The field of assisted reproduction is renowned for its remarkable advances and constant pushing forward of research boundaries in an effort to offer innovative and effective methods for enhancing fertility. Accompanying these advances, however, are physiological, psychological, and bioethical consequences that must be considered. These concomitant advances and consequences make assisted reproduction an excellent educational paradigm for inculcating responsible conduct in both research and clinical practice. Ultimately, responsible conduct rests on the ethical researcher and clinician. Here, we present the as-yet unapproved, contentious assisted reproductive technology of mitochondrial replacement transfer (MRT) as an ideal educational platform to foster the responsible conduct of research by advancing dialogue among multi-disciplinary scholars, researchers, and students. Using a likely future case, we present the basic science, legal, and ethical considerations, and the pedagogical principles and strategies for using MRT as an effective educational paradigm. Society will benefit when the ethical issues inherent in creating children with three genetic parents as well as germline interference are discussed across multiple academic levels that include researchers, legal experts, bioethicists, and government-appointed commissions. Furthermore, undergraduate and graduate students should be included because they will likely determine the ethical fates of these biotechnologies. While emerging assisted reproduction technologies such as MRT are highly complex and will take years to be readily available for patients in need, now is the time to consider their scientific, legal, ethical, and cultural/religious implications for ensuring the responsible conduct of research.
doi:10.1128/jmbe.v15i2.873
PMCID: PMC4278475  PMID: 25574276
5.  Empirical research in bioethical journals. A quantitative analysis 
Journal of Medical Ethics  2006;32(4):240-245.
Objectives
The objective of this research is to analyse the evolution and nature of published empirical research in the fields of medical ethics and bioethics.
Design
Retrospective quantitative study of nine peer reviewed journals in the field of bioethics and medical ethics (Bioethics, Cambridge Quarterly of Healthcare Ethics, Hastings Center Report, Journal of Clinical Ethics, Journal of Medical Ethics, Kennedy Institute of Ethics Journal, Nursing Ethics, Christian Bioethics, andTheoretical Medicine and Bioethics).
Results
In total, 4029 articles published between 1990 and 2003 were retrieved from the journals studied. Over this period, 435 (10.8%) studies used an empirical design. The highest percentage of empirical research articles appeared in Nursing Ethics (n = 145, 39.5%), followed by the Journal of Medical Ethics (n = 128, 16.8%) and the Journal of Clinical Ethics (n = 93, 15.4%). These three journals account for 84.1% of all empirical research in bioethics published in this period. The results of the χ2 test for two independent samples for the entire dataset indicate that the period 1997–2003 presented a higher number of empirical studies (n = 309) than did the period 1990–1996 (n = 126). This increase is statistically significant (χ2 = 49.0264, p<.0001). Most empirical studies employed a quantitative paradigm (64.6%, n = 281). The main topic of research was prolongation of life and euthanasia (n = 68).
Conclusions
We conclude that the proportion of empirical research in the nine journals increased steadily from 5.4% in 1990 to 15.4% in 2003. It is likely that the importance of empirical methods in medical ethics and bioethics will continue to increase.
doi:10.1136/jme.2004.011478
PMCID: PMC2565792  PMID: 16574880
empirical ethics; retrospective quantitative study; empirical methods in bioethics
6.  Ethics reporting practices in clinical research publications: A review of four Indian journals 
Background:
Manuscript authors of scientific journals are expected to report if their studies were conducted according to international and national ethical guidelines and inform readers regarding ethics approval and informed consent obtained from participants and/or their legally acceptable representative/s. In the present study we assessed the reporting practices of ethics approval and informed consent (assent in case of pediatric studies) in four Indian journals.
Materials and Methods:
Original research articles published over a period of 4 years (2009-2012) in four major national clinical journals, viz. Journal of Association of Physicians of India (JAPI), Indian Journal of Surgery (IJS), Journal of Obstetrics and Gynecology of India (JOGI), and Indian Journal of Orthopedics (IJO) were reviewed with regard to documentation of ethics approval and written informed consent and assent in case of pediatric participants.
Results:
We reviewed 673 research articles and found that, overall ethical approval was mentioned in 163 (24.2%) and informed consent or assent was mentioned in 179 (26.5%) articles in all four journals. Individually we found, in JAPI of the 174 manuscripts reviewed, 74 (42.5%) reported having obtained approval from the ethics committee and 68 (39.1%) reported taking written informed consent from participants. In IJS of 123 manuscripts, 18 (14.6%) reported ethics committee approval and 20 (16.2%) reported informed consent from participants. In JOGI of 152 manuscripts, 21 (13.8%) reported ethics committee approval while 49 (32.2%) reported informed consent from participants. In IJO, of 224 manuscripts, 50 (22.3%) reported ethics committee approval and 42 (18.7%) reported obtaining informed consent.
Conclusion:
Majority of the publications did not provide information regarding compliance to ethical guidelines in spite of the availability of various guidelines. Thus, there is a need for awareness and training on bioethics for authors, reviewers, and editors of biomedical journals.
doi:10.4103/2229-3485.134316
PMCID: PMC4073550  PMID: 24987584
Ethical approval; ethics committee; informed consent
7.  Assisted Reproductive Technology after the Birth of Louise Brown 
Background
Public interest in Assisted Reproductive Technology (ART) has remained high since the birth of the world’s first in vitro fertilization baby, Louise Brown, in the United Kingdom. ART allows scientists to manipulate the fertilization process in order to bypass some pathological obstacles such as blocked fallopian tubes and non-functioning ovaries in the females, and blocked vas deferens and low sperm count in the males. The purpose was to provide a historical outline and identify the researches that most contributed to ART.
Methods
A review of published experimental and clinical studies of assisted reproduction carried out at the University of Bristol library website (MetaLib®). A cross-search of seven different medical databases (AMED-Allied and Complementary Medicine Database, BIOSIS Previews on Web of Knowledge, Cochrane Library, Embase, and the Medline on Web of Knowledge, OvidSP and PubMed) was completed by using the key words to explore the major milestones and progress in the development and implementation of ART.
Results
A speedy advancement in the development of different assisted reproductive techniques makes infertility problem more treatable than it ever had been.
Conclusion
Although no other field in the medicine has integrated new knowledge into the daily practice more quickly than ART yet, there is a need for social research to counterbalance the dominance of biomedical one, in particular the people’s actual experiences and expectations of ART.
PMCID: PMC3799275  PMID: 24163793
Assisted reproductive technology; History; Infertility management; Louise Brown; Milestones; Timelines
8.  Approaches to improve the diagnosis and management of infertility 
Human Reproduction Update  2009;15(4):391-408.
BACKGROUND
Recent advances in our understanding of the causes of infertility and of assisted reproductive technology (ART) have led to the development of complex diagnostic tools, prognostic models and treatment options. The Third Evian Annual Reproduction (EVAR) Workshop Meeting was held on 26–27 April 2008 to evaluate evidence supporting current approaches to the diagnosis and management of infertility and to identify areas for future research efforts.
METHODS
Specialist reproductive medicine clinicians and scientists delivered presentations based on published literature and ongoing research on patient work-up, ovarian stimulation and embryo quality assessment during ART. This report is based on the expert presentations and subsequent group discussions and was supplemented with publications from literature searches and the authors' knowledge.
RESULTS
It was agreed that single embryo transfer (SET) should be used with increasing frequency in cycles of ART. Continued improvements in cryopreservation techniques, which improve pregnancy rates using supernumerary frozen embryos, are expected to augment the global uptake of SET. Adaptation and personalization of fertility therapy may help to optimize efficacy and safety outcomes for individual patients. Prognostic modelling and personalized management strategies based on individual patient characteristics may prove to represent real progress towards improved treatment. However, at present, there is limited good-quality evidence to support the use of these individualized approaches.
CONCLUSIONS
Greater quality control and standardization of clinical and laboratory evaluations are required to optimize ART practices and improve individual patient outcomes. Well-designed, good-quality studies are required to drive improvements to the diagnosis and management of ART processes.
doi:10.1093/humupd/dmp012
PMCID: PMC2691653  PMID: 19380415
infertility work-up; in vitro fertilization; ovarian response; predictive factors; single embryo transfer
9.  The biology of infertility: research advances and clinical challenges 
Nature medicine  2008;14(11):1197-1213.
Reproduction is required for the survival of all mammalian species, and thousands of essential ‘sex’ genes are conserved through evolution. Basic research helps to define these genes and the mechanisms responsible for the development, function and regulation of the male and female reproductive systems. However, many infertile couples continue to be labeled with the diagnosis of idiopathic infertility or given descriptive diagnoses that do not provide a cause for their defect. For other individuals with a known etiology, effective cures are lacking, although their infertility is often bypassed with assisted reproductive technologies (ART), some accompanied by safety or ethical concerns. Certainly, progress in the field of reproduction has been realized in the twenty-first century with advances in the understanding of the regulation of fertility, with the production of over 400 mutant mouse models with a reproductive phenotype and with the promise of regenerative gonadal stem cells. Indeed, the past six years have witnessed a virtual explosion in the identification of gene mutations or polymorphisms that cause or are linked to human infertility. Translation of these findings to the clinic remains slow, however, as do new methods to diagnose and treat infertile couples. Additionally, new approaches to contraception remain elusive. Nevertheless, the basic and clinical advances in the understanding of the molecular controls of reproduction are impressive and will ultimately improve patient care.
doi:10.1038/nm.f.1895
PMCID: PMC3786590  PMID: 18989307
10.  In memoriam: Celso-Ramon Garcia, M.D. (1922–2004), reproductive medicine visionary 
This article traces the career of Celso-Ramon Garcia (1922–2004), noted physician, educator, and internationally renowned pioneer in the field of reproductive endocrinology. His work helped to formulate oral contraceptives used by millions of women throughout the world. Garcia's research collaborators included Gregory Pincus and John Rock, who together finalized the landmark clinical data needed to secure initial FDA approval for "the pill" in 1960. In addition to Garcia's monumental work in contraceptive endocrinology, his scholarly interests encompassed physiology of the menopause, minimally invasive reproductive surgery, as well as psychological aspects of infertility. Closely identified with the University of Pennsylvania, Garcia was instrumental in establishing the first formal clinical program in reproductive biology and influenced countless young scientists whose training he supervised and mentored. His distinguished career was emblematic of the best of the medical profession, characterized by compassion, intellect, and a sincere desire to help others. Our manuscript outlines Garcia's wide range of interests, acknowledges his superior fund of knowledge, and honors his humanitarian spirit – all of which contributed to an impressive legacy of medical discoveries. The impact of Prof. Garcia's work will continue to be felt for many years.
doi:10.1186/1743-1050-2-2
PMCID: PMC548289  PMID: 15673473
11.  A Cross-Sectional Study of the Psychosexual Impact of Cancer-Related Infertility in Women: Third-Party Reproductive Assistance 
Introduction
This study empirically assessed emotional and sexual functioning, reproductive concerns, and quality of life (QOL) of cancer-related infertile women in comparison to those without a cancer history and explored awareness of third-party reproduction options in cancer survivors.
Methods
One hundred twenty-two cancer survivors (Gynecologic and Bone Marrow/Stem Cell Transplant) with cancer-related infertility and 50 non-cancer infertile women completed a self-report survey assessing: reproductive concerns(RCS), mood(CES-D), distress(IES), sexual function(FSFI), menopause(SCL), QOL(SF-12), relationships(ADAS), and exploratory (reproductive options) items.
Results
Cancer survivors exhibited greater sexual dysfunction and lower physical QOL than non-cancer infertile women (P<0.001). No significant group differences were identified for mood (CES-D), mental health QOL (SF-12), reproductive concerns (RCS), and relationship satisfaction (ADAS). All groups scored in the FSFI range of sexual dysfunction, and with RCS scores above published means. Multivariate comparisons showed comparable depression and distress levels for all groups, but cancer survivors had poorer physical QOL [F(5,146)=4.22, P<0.01]. A significant effect was also found for knowledge of third-party reproductive options on depression and distress levels [F(3,97)=4.62, P<0.01]. Adjusted means demonstrated higher depression and distress scores for women with perceived unmet informational needs.
Conclusions
Overall, loss of fertility was an emotionally challenging experience for women regardless of its cause. Cancer survivors were found to have lower scores of physical QOL and sexual function than non-cancer infertile women. Unmet informational needs about reproductive options appeared to be associated with negative mood and increased distress in cancer survivors.
Implications for Cancer Survivors
Targeted interventions to increase knowledge about reproductive options could be of great assistance to women pursuing parenthood in cancer survivorship. Additionally, intervention studies to improve sexual functioning and QOL in women with cancer-related infertility should be a priority of future research.
doi:10.1007/s11764-010-0121-2
PMCID: PMC3701949  PMID: 20373042
cancer; infertility; survivorship; quality of life; third-party parenting
12.  Current status of assisted reproductive technology in Korea, 2009 
Obstetrics & Gynecology Science  2013;56(6):353-361.
Great advances have been made in the field of assisted reproductive technology (ART) since the first in vitro fertilization (IVF) baby was born in Korea in the year of 1985. However, it deserve to say that the invaluable data from fertility centers may serve as a useful source to find out which factors affect successful IVF outcome and to offer applicable information to infertile patients and fertility clinics. This article intended to report the status of ART in 2009 Korean Society of Obstetrics and Gynecology surveyed. The current survey was performed to assess the status and success rate of ART performed in Korea, between January 1 and December 31, 2009. Reporting forms had been sent out to IVF centers via e-mail, and collected by e-mail as well in 2012. With International Committee Monitoring Assisted Reproductive Technologies recommendation, intracytoplasmic sperm injection (ICSI) and non-ICSI cases have been categorized and also IVF-ET cases involving frozen embryo replacement have been surveyed separately. Seventy-four centers have reported the treatment cycles initiated in the year of 2009, and had performed a total of 27,947 cycles of ART treatments. Among a total of 27,947 treatment cycles, IVF and ICSI cases added up to 22,049 (78.9%), with 45.3% IVF without ICSI and 54.7% IVF with ICSI, respectively. Among the IVF and ICSI patients, patients confirmed to have achieved clinical pregnancy was 28.8% per cycle with oocyte retrieval, and 30.9% per cycle with embryo transfer. The most common number of embryos transferred in 2009 is three embryos (40.4%), followed by 2 embryos (28.4%) and a single embryo transferred (13.6%). Among IVF and ICSI cycles that resulted in multiple live births, twin pregnancy rate was 45.3% and triple pregnancy rate was 1.1%. A total of 191 cases of oocyte donation had been performed to result in 25.0% of live birth rate. Meanwhile, a total of 5,619 cases of frozen embryo replacement had been performed with 33.7% of clinical pregnancy rate per cycle with embryo transfer. When comparing with international registry data, clinical pregnancy rate per transfer from fresh IVF cycles including ICSI (34.1%,) was comparable to clinical pregnancy rate per transfer in European Society for Human Reproduction and Embryology report was 32.5% though lower than 45.0% for USA data. There was no remarkable difference in status of assisted reproductive technology in Korea between the current report and the data reported in 2008. The age of women trying to get pregnant was reconfirmed to be the most important factor that may have impact on success of ART treatment.
doi:10.5468/ogs.2013.56.6.353
PMCID: PMC3859020  PMID: 24396813
International Committee for Monitoring Assisted Reproductive Technologies; Korea; Reproductive techniques; Survey
13.  Fertility Preservation 
Mayo Clinic Proceedings  2011;86(1):45-49.
Of the estimated 1.5 million men and women who were diagnosed as having cancer in 2010, approximately 10% are younger than 45 years. For these individuals, cancer treatment can be lifesaving but can permanently affect reproductive capacity. The American Society of Clinical Oncology has recommended that oncologists discuss the possibility of infertility with reproductive-age cancer patients and offer referral for fertility preservation consultation and therapy. Fertility preservation is an emerging field that offers treatment aimed at protecting future reproductive ability for individuals with cancer or other serious illnesses. Although fertility preservation strategies vary by patient age and sex, many allow patients to store gametes or reproductive tissues for potential future use to create offspring. As an emerging discipline, many questions remain about the role of fertility preservation. We performed a MEDLINE search from 1950 to June 2010 using the following MeSH terms: amenorrhea; antineoplastic agents; ovarian failure; premature; infertility, female; fertility preservation; infertility, male; adolescent and cancer; child and cancer; cryopreservation; and reproductive technologies, assisted. Studies considered for inclusion included those written in English and published before June 2010.
doi:10.4065/mcp.2010.0564
PMCID: PMC3012633  PMID: 21193655
14.  Levels of evidence: a comparison between top medical journals and general pediatric journals 
BMC Pediatrics  2015;15:3.
Background
Given the large number of publications in all fields of practice, it is essential that clinicians focus on the resources that provide the highest level of evidence (LOE). We sought to determine the LOE that exists in the field of pediatrics, present in the general pediatric as well as high impact clinical literature.
Methods
Clinical pediatric literature, published between April 2011 and March 2012 inclusive in high-impact clinical journals (HICJ) (New England Journal of Medicine, Journal of the American Medical Association, & The Lancet) and the highest-impact general pediatric journals (GPJ) (Pediatrics, Journal of Pediatrics, & Archives of Pediatrics & Adolescent Medicine), was assessed. In addition to the LOE, articles were evaluated on criteria including subspecialty within pediatrics, number of authors, number of centers, and other parameters. Eligible level I randomized control trials were appraised using the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Results
Of 6511 articles screened, 804 met inclusion criteria (68 in HICJ and 736 in GPJ). On average, LOE in pediatrics-focused articles within The Lancet were significantly higher than all GPJ (p < 0.05). Average CONSORT scores were significantly higher in HICJ vs. GPJ (15.2 vs. 13.6, respectively, p < 0.001).
Conclusions
LOE and quality of randomized control trials within the pediatric field is highest within HICJ, however, only represent a small proportion of data published. Following CONSORT criteria, and promoting studies of high LOE may allow authors and readers to turn to journals and articles of greater clinical impact.
doi:10.1186/s12887-015-0324-9
PMCID: PMC4336754
Evidence-based medicine; Data quality; Journal impact factor
15.  Exposure to hazardous substances and male reproductive health: a research framework. 
Environmental Health Perspectives  2000;108(9):803-813.
The discovery in the mid-1970s that occupational exposures to pesticides could diminish or destroy the fertility of workers sparked concern about the effects of hazardous substances on male reproductive health. More recently, there is evidence that sperm quantity and quality may have declined worldwide, that the incidence of testicular cancer has progressively increased in many countries, and that other disorders of the male reproductive tract such as hypospadias and cryptorchidism may have also increased. There is growing concern that occupational factors and environmental chemical exposures, including in utero and childhood exposures to compounds with estrogenic activity, may be correlated with these observed changes in male reproductive health and fertility. We review the evidence and methodologies that have contributed to our current understanding of environmental effects on male reproductive health and fertility and discuss the methodologic issues which confront investigators in this area. One of the greatest challenges confronting researchers in this area is assessing and comparing results from existing studies. We elaborate recommendations for future research. Researchers in the field of male reproductive health should continue working to prioritize hazardous substances; elucidate the magnitude of male reproductive health effects, particularly in the areas of testicular cancer, hypospadias, and cryptorchidism; develop biomarkers of exposure to reproductive toxins and of reproductive health effects for research and clinical use; foster collaborative interdisciplinary research; and recognize the importance of standardized laboratory methods and sample archiving.
PMCID: PMC2556920  PMID: 11017884
16.  The Structure of Medical Informatics Journal Literature 
Abstract Objective: Medical informatics is an emergent interdisciplinary field described as drawing upon and contributing to both the health sciences and information sciences. The authors elucidate the disciplinary nature and internal structure of the field.
Design: To better understand the field's disciplinary nature, the authors examine the intercitation relationships of its journal literature. To determine its internal structure, they examined its journal cocitation patterns.
Measurements: The authors used data from the Science Citation Index (SCI) and Social Science Citation Index (SSCI) to perform intercitation studies among productive journal titles, and software routines from SPSS to perform multivariate data analyses on cocitation data for proposed core journals.
Results: Intercitation network analysis suggests that a core literature exists, one mark of a separate discipline. Multivariate analyses of cocitation data suggest that major focus areas within the field include biomedical engineering, biomedical computing, decision support, and education. The interpretable dimensions of multidimensional scaling maps differed for the SCI and SSCI data sets. Strong links to information science literature were not found.
Conclusion: The authors saw indications of a core literature and of several major research fronts. The field appears to be viewed differently by authors writing in journals indexed by SCI from those writing in journals indexed by SSCI, with more emphasis placed on computers and engineering versus decision making by the former and more emphasis on theory versus application (clinical practice) by the latter.
PMCID: PMC61326  PMID: 9760393
17.  Evaluation Criteria for Publishing in Top-Tier Journals in Environmental Health Sciences and Toxicology 
Environmental Health Perspectives  2011;119(7):896-899.
Background: Trying to publish a paper in a top-rated peer-reviewed journal can be a difficult and frustrating experience for authors. It is important that authors understand the general review process before submitting manuscripts for publication.
Objectives: Editors-in-chief and associate editors from top-tier journals such as Environmental Health Perspectives (EHP), Toxicological Sciences, Journal of Pharmacology and Experimental Therapeutics, and Chemical Research in Toxicology were asked to provide guidance concerning the writing and submission of papers to their journals.
Discussion: The editors reviewed the manuscript review process for their journals, elaborated on the evaluation criteria for reviewing papers, and provided advice for future authors in preparing their papers.
Conclusions: The manuscript submission process was similar for all of the journals with the exception of EHP that includes an initial screening in which about two-thirds of submitted papers are returned to the authors without review. The evaluation criteria used by the journals were also similar. Papers that are relevant to the scope of the journal, are innovative, significantly advance the field, are well written, and adhere to the instructions to authors have a higher likelihood of being accepted. The editors advised potential authors to ensure that the topic of the paper is within the scope of the journal, represents an important problem, is carefully prepared according to the instructions to authors, and to seek editorial assistance if English is not the primary language of the authors.
doi:10.1289/ehp.1003280
PMCID: PMC3222983  PMID: 21414890
environmental health sciences; evaluation criteria; peer review; top-tier journals; toxicology
18.  Conflicts of Interest at Medical Journals: The Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study 
PLoS Medicine  2010;7(10):e1000354.
Andreas Lundh and colleagues investigated the effect of publication of large industry-supported trials on citations and journal income, through reprint sales, in six general medical journals
Background
Transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue.
Methods and Findings
We sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996–1997 and 2005–2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005–2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005–2006.
Conclusions
Publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Medical journals publish many different types of papers that inform doctors about the latest research advances and the latest treatments for their patients. They publish articles that describe laboratory-based research into the causes of diseases and the identification of potential new drugs. They publish the results of early clinical trials in which a few patients are given a potential new drug to check its safety. Finally and most importantly, they publish the results of randomized controlled trials (RCTs). RCTs are studies in which large numbers of patients are randomly allocated to different treatments without the patient or the clinician knowing the allocation and the efficacy of the various treatments compared. RCTs are best way of determining whether a new drug is effective and have to be completed before a drug can be marketed. Because RCTs are very expensive, they are often supported by drug companies. That is, drug companies provide grants or drugs for the trial or assist with data analysis and/or article preparation.
Why Was This Study Done?
Whenever a medical journal publishes an article, the article's authors have to declare any conflicts of interest such as financial gain from the paper's publication. Conflict of interest statements help readers assess papers—an author who owns the patent for a drug, for example, might put an unduly positive spin on his/her results. The experts who review papers for journals before publication provide similar conflict of interest statements. But what about the journal editors who ultimately decide which papers get published? The International Committee of Medical Journal Editors (ICMJE), which produces medical publishing guidelines, states that: “Editors who make final decisions about manuscripts must have no personal, professional, or financial involvement in any of the issues that they might judge.” However, the publication of industry-supported RCTs might create “indirect” conflicts of interest for journals by boosting the journal's impact factor (a measure of a journal's importance based on how often its articles are cited) and its income through the sale of reprints to drug companies. In this study, the researchers investigate whether the publication of industry-supported RCTs influences the impact factors and finances of six major medical journals.
What Did the Researchers Do and Find?
The researchers determined which RCTs published in the New England Journal of Medicine (NEJM), the British Medical Journal (BMJ), The Lancet, and three other major medical journals in 1996–1997 and 2005–2006 were supported wholly, partly, or not at all by industry. They then used the online academic citation index Web of Science to calculate an approximate impact factor for each journal for 1998 and 2007 and calculated the effect of the published RCTs on the impact factor. The proportion of RCTs with sole industry support varied between journals. Thus, 32% of the RCTs published in the NEJM during both two-year periods had industry support whereas only 7% of the RCTs published in the BMJ in 2005–2006 had industry support. Industry-supported trials were more frequently cited than RCTs with other types of support and omitting industry-supported RCTs from impact factor calculations decreased all the approximate journal impact factors. For example, omitting all RCTs with industry or mixed support decreased the 2007 BMJ and NEJM impact factors by 1% and 15%, respectively. Finally, the researchers asked each journal's editor about their journal's income from industry sources. For the BMJ and The Lancet, the only journals that provided this information, income from reprint sales was 3% and 41%, respectively, of total income in 2005–2006.
What Do These Findings Mean?
These findings show that the publication of industry-supported RCTs was associated with an increase in the approximate impact factors of these six major medical journals. Because these journals publish numerous RCTs, this result may not be generalizable to other journals. These findings also indicate that income from reprint sales can be a substantial proportion of a journal's total income. Importantly, these findings do not imply that the decisions of editors are affected by the possibility that the publication of an industry-supported trial might improve their journal's impact factor or income. Nevertheless, the researchers suggest, journals should live up to the same principles related to conflicts of interest as those that they require from their authors and should routinely disclose information on the source and amount of income that they receive.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000354.
This study is further discussed in a PLoS Medicine Perspective by Harvey Marcovitch
The International Committee of Medical Journal Editors provides information about the publication of medical research, including conflicts of interest
The World Association of Medical Editors also provides information on conflicts of interest in medical journals
Information about impact factors is provided by Thomson Reuters, a provider of intelligent information for businesses and professionals; Thomson Reuters also runs Web of Science
doi:10.1371/journal.pmed.1000354
PMCID: PMC2964336  PMID: 21048986
19.  Tracking Official Development Assistance for Reproductive Health in Conflict-Affected Countries 
PLoS Medicine  2009;6(6):e1000090.
Preeti Patel and colleagues report inequity in the disbursement of official development assistance for reproductive health between countries affected by conflict and those unaffected.
Background
Reproductive health needs are particularly acute in countries affected by armed conflict. Reliable information on aid investment for reproductive health in these countries is essential for improving the efficiency and effectiveness of aid. The purpose of this study was to analyse official development assistance (ODA) for reproductive health activities in conflict-affected countries from 2003 to 2006.
Methods and Findings
The Creditor Reporting System and the Financial Tracking System databases were the chosen data sources for the study. ODA disbursement for reproductive health activities to 18 conflict-affected countries was analysed for 2003, 2004, 2005, and 2006. An average of US$20.8 billion in total ODA was disbursed annually to the 18 conflict-affected countries between 2003 and 2006, of which US$509.3 million (2.4%) was allocated to reproductive health. This represents an annual average of US$1.30 disbursed per capita in the 18 sampled countries for reproductive health activities. Non-conflict-affected least-developed countries received 53.3% more ODA for reproductive health activities than conflict-affected least-developed countries, despite the latter generally having greater reproductive health needs. ODA disbursed for HIV/AIDS prevention and treatment increased by 119.4% from 2003 to 2006. The ODA disbursed for other direct reproductive health activities declined by 35.9% over the same period.
Conclusions
This study provides evidence of inequity in disbursement of reproductive health ODA between conflict-affected countries and non-conflict-affected countries, and between different reproductive health activities. These findings and the study's recommendations seek to support initiatives to make aid financing more responsive to need in the context of armed conflict.
Editors' Summary
Background
Reproductive health concerns the bodily functions and systems that are involved in conceiving and bearing offspring. A reproductively healthy person is able to have a responsible, satisfying and safe sex life and to reproduce if and when they chose to do so. More specifically, to ensure their reproductive health, both men and women need access to safe and effective birth control methods, they need to know how to avoid sexually transmitted diseases (including HIV/AIDS), and they need access to treatment should they become infected. Women also need access to appropriate health-care services to safeguard their own health and their offspring's health during pregnancy and childbirth. Reproductive health is essential for the wellbeing of individuals and families and for the social and economic development of nations. Consequently, some of the official development assistance (ODA) given to developing countries by wealthier nations and by international agencies is being used to improve reproductive health. Indeed, several of the Millennium Development Goals (internationally agreed targets designed to eradicate global poverty by 2015) are directly related to reproductive health, including the improvement of maternal health and the control of HIV/AIDS.
Why Was This Study Done?
Many developing countries, such as Afghanistan, the Democratic Republic of Congo, Iraq, and Sudan, are experiencing violent conflicts. Such conflicts tend to slow down the development of low-income countries, and can also cause harm to reproductive health by damaging the health-service infrastructure and by increasing exposure to sexual violence. Although conflict-affected low-income countries rely heavily on international and humanitarian aid for basic health-care provision, there is little reliable information about how much of this aid is invested in reproductive health in such countries. This information is needed to ensure that development aid is used effectively. In this study, therefore, the researchers analyze the amount of ODA disbursed (the amount of official development money paid to recipient countries) for reproductive health activities in conflict-affected countries between 2003 and 2006.
What Did the Researchers Do and Find?
The researchers identified eighteen countries (mostly “least-developed” countries as defined by the Organisation for Economic Co-operation and Development; OEDC) that had been at war at sometime during the study period. They obtained information on ODA disbursements for reproductive health activities mainly from the Creditor Reporting System (CRS) database, which is maintained by the OECD, but also from the Financial Tracking System (FTS) database, which is maintained by the United Nations Office for the Coordination of Humanitarian Affairs. An average of US$20.8 billion in ODA was disbursed annually to the 18 conflict-affected countries between 2003 and 2006. Only US$509.3 million (2.4%) of this was allocated to reproductive health. Put another way, each person living in these conflict-affected countries received US$1.30 per year for their reproductive health needs. By contrast, people in non-conflict-affected least-developed countries each received 50% more ODA for reproductive health activities, even though these countries often had better reproductive health indicators than the conflict-affected countries. The researchers also found that nearly half of ODA disbursed for reproductive health was used for HIV/AIDS-related activities. This portion of ODA increased slightly during the study period in the conflict-affected countries whereas ODA disbursed for other reproductive health activities fell by a third.
What Do These Findings Mean?
Although these findings do not take into account money provided to conflict-affected developing countries for reproductive health activities by large philanthropic organizations, they nevertheless reveal an inequality between conflict-affected and non-conflict affected countries in terms of the development money provided for reproductive health. This is a worrying finding given that reproductive health tends to suffer in countries affected by war and poor reproductive health can slow down development. The findings of this study also suggest that funding for non-HIV reproductive health activities is declining in conflict-affected countries. Importantly, they also highlight additional research that is needed to ensure that donors of development aid can be more responsive in future to the reproductive health needs of conflict-affected countries.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000090.
This study is further discussed in a PLoS Medicine Perspective by Paul Spiegel and colleagues
The World Health organization provides information about reproductive health, including information on its 2004 global strategy for reproductive health (in several languages)
The US Centers for Disease Control and Prevention also provides information on reproductive health (in English and Spanish)
Wikipedia has a page on reproductive health (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages
The United Nations provides information on the Millennium Development Goals
The Organisation for Economic Cooperation and Development provides information on ODA through its Creditor Reporting System database; the United Nations Office for the Coordination of Humanitarian Affairs provides similar information for other donors through its Financial Tracking System database
The Reproductive Health Response in Conflict Consortium promotes access to reproductive health programs in emergencies and advocates for policies that support reproductive health of persons affected by armed conflict
doi:10.1371/journal.pmed.1000090
PMCID: PMC2682761  PMID: 19513098
20.  Methodology and Analytic Techniques Used in Clinical Research: Associations With Journal Impact Factor 
Obstetrics and gynecology  2009;114(4):877-884.
Objective
To describe research methodology and statistical reporting of published articles in high impact factor, general medical journals compared to moderate impact factor obstetric and gynecology journals.
Methods
A cross-sectional analysis was performed on 371 articles published from January to June 2006, in 6 journals (high impact factor group—Journal of the American Medical Association, Lancet, the New England Journal of Medicine; moderate impact factor group—American Journal of Obstetrics and Gynecology, British Journal of Obstetrics and Gynecology, and Obstetrics & Gynecology). Articles were classified by level of evidence. Data abstracted from each article included: number of authors, clearly stated hypothesis, sample size/power calculations, statistical measures, and use of regression analysis. Univariable analyses were performed to evaluate differences between the high and moderate impact factor groups.
Results
The majority of published reports were observational studies (50%), followed by randomized controlled trials ([RCTs] 24%), case reports (14%), systematic reviews (6%), case series (1%), and other study types (4%). Within the high factor impact group, 35% were RCTs compared to 12% in the moderate impact group (RR 2.9, 95% CI 1.9-4.4). Recommended statistical reporting (eg point estimates with measures of precision) was more common in the high impact group (P<0.005).
Conclusions
The proportion of RCTs published among the high impact factor group was 3 times that of the moderate group. Efforts to provide the highest level of evidence and statistical reporting have potential to improve the quality of reports in the medical literature available for clinical decision making.
doi:10.1097/AOG.0b013e3181b5c9e8
PMCID: PMC3121005  PMID: 19888048
21.  Assisted Reproduction: What factors interfere in the professional's decisions? Are single women an issue? 
BMC Women's Health  2011;11:21.
Background
With the development of medical technology, many countries around the world have been implementing ethical guidelines and laws regarding Medically Assisted Reproduction (MAR). A physician's reproductive decisions are not solely based on technical criteria but are also influenced by society values. Therefore, the aim of this study was to analyze the factors prioritized by MAR professionals when deciding on whether to accept to perform assisted reproduction and to show any existing cultural differences.
Methods
Cross-sectional study involving 224 healthcare professionals working with assisted reproduction in Brazil, Italy, Germany and Greece. Instrument used for data collection: a questionnaire, followed by the description of four special MAR cases (a single woman, a lesbian couple, an HIV discordant couple and gender selection) which included case-specific questions regarding the professionals' decision on whether to perform the requested procedure as well as the following factors: socio-demographic variables, moral and legal values as well as the technical aspects which influence decision-making.
Results
Only the case involving a single woman who wishes to have a child (without the intention of having a partner in the future) demonstrated significant differences. Therefore, the study was driven towards the results of this case specifically. The analyses we performed demonstrated that professionals holding a Master's Degree, those younger in age, female professionals, those having worked for less time in reproduction, those in private clinics and Brazilian health professionals all had a greater tendency to perform the procedure in that case. A multivariate analysis demonstrated that the reasons for the professional's decision to perform the procedure were the woman's right to gestate and the duty of MAR professionals to help her. The professionals who decided not to perform the procedure identified the woman's marital status and the child's right to a father as the reason to withhold treatment.
Conclusion
The study indicates differences among countries in the evaluation of the single woman case. It also discloses the undervaluation of bioethics committees and the need for a greater participation of healthcare professionals in debates on assisted reproduction laws.
doi:10.1186/1472-6874-11-21
PMCID: PMC3125239  PMID: 21627812
22.  Prerequsite result of routine human immunodeficiency virus serology among infertile women before assisted reproduction technology 
Background:
Sexually transmitted diseases such as Human Immunodeficiency Virus (HIV) which causes or induces incurable fatal infections have been transmitted through Assisted Reproduction Technology and from infected mothers to the fetus or new born.
Aim:
The aim of this study is to determine the prevalence of this chronic viral agent among infertile women recruited for Assisted Reproduction Technique programme in Benin City, Nigeria.
Materials and Method:
Sera (serum) from Five hundred and Ninety infertile women attending Human Reproduction Research Programme/In-vitro fertilization Center at University of Benin Teaching Hospital were screened for the presence of Human Immunodeficiency Virus antibody using three algorithm or techniques of Determine, Unigold and Stat Pack kits. The age range of the infertile women was 20-49 years.
Result:
28 (4.7%) out of Five Hundred and fifty infertile women recruited for Assisted Reproduction Technique and screened for Human Immunodeficiency Virus antibody were seropositive with increase in prevalence of 10. 0%, 8.5% and 7.5% among infertile women in age groups of (20 – 24), (25 – 29)yrs and (30 – 34)yrs. Chi-square statistical analysis of data shows insignificance in seroprevalence rate in relation to the number of infertile women screened (P > 0.0001) but the screening of these infertile women for the presence Human Immunodeficiency Virus should continue due to the attendant effects.
Conclusion:
Infertile women who are Human Immunodeficiency Virus carriers give a new dimension to assisted reproductive techniques. This will no doubt help to prevent further spread and adverse pregnancy outcome.
doi:10.4297/najms.2011.3198
PMCID: PMC3336912  PMID: 22540091
Human immunodeficiency virus; HIV; serology; infertile women and assisted reproduction technology
23.  Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policy 
European Journal of Human Genetics  2013;21(Suppl 2):S1-S21.
In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and assisted reproductive technology (ART), and published an extended background paper, recommendations and two Editorials. Seven years later, in March 2012, a follow-up interdisciplinary workshop was held, involving representatives of both professional societies, including experts from the European Union Eurogentest2 Coordination Action Project. The main goal of this meeting was to discuss developments at the interface between clinical genetics and ARTs. As more genetic causes of reproductive failure are now recognised and an increasing number of patients undergo testing of their genome before conception, either in regular health care or in the context of direct-to-consumer testing, the need for genetic counselling and preimplantation genetic diagnosis (PGD) may increase. Preimplantation genetic screening (PGS) thus far does not have evidence from randomised clinical trials to substantiate that the technique is both effective and efficient. Whole-genome sequencing may create greater challenges both in the technological and interpretational domains, and requires further reflection about the ethics of genetic testing in ART and PGD/PGS. Diagnostic laboratories should be reporting their results according to internationally accepted accreditation standards (International Standards Organisation – ISO 15189). Further studies are needed in order to address issues related to the impact of ART on epigenetic reprogramming of the early embryo. The legal landscape regarding assisted reproduction is evolving but still remains very heterogeneous and often contradictory. The lack of legal harmonisation and uneven access to infertility treatment and PGD/PGS fosters considerable cross-border reproductive care in Europe and beyond. The aim of this paper is to complement previous publications and provide an update of selected topics that have evolved since 2005.
doi:10.1038/ejhg.2013.219
PMCID: PMC3831061  PMID: 24225486
24.  What do evidence-based secondary journals tell us about the publication of clinically important articles in primary healthcare journals? 
BMC Medicine  2004;2:33.
Background
We conducted this analysis to determine i) which journals publish high-quality, clinically relevant studies in internal medicine, general/family practice, general practice nursing, and mental health; and ii) the proportion of clinically relevant articles in each journal.
Methods
We performed an analytic survey of a hand search of 170 general medicine, general healthcare, and specialty journals for 2000. Research staff assessed individual articles by using explicit criteria for scientific merit for healthcare application. Practitioners assessed the clinical importance of these articles. Outcome measures were the number of high-quality, clinically relevant studies published in the 170 journal titles and how many of these were published in each of four discipline-specific, secondary "evidence-based" journals (ACP Journal Club for internal medicine and its subspecialties; Evidence-Based Medicine for general/family practice; Evidence-Based Nursing for general practice nursing; and Evidence-Based Mental Health for all aspects of mental health). Original studies and review articles were classified for purpose: therapy and prevention, screening and diagnosis, prognosis, etiology and harm, economics and cost, clinical prediction guides, and qualitative studies.
Results
We evaluated 60,352 articles from 170 journal titles. The pass criteria of high-quality methods and clinically relevant material were met by 3059 original articles and 1073 review articles. For ACP Journal Club (internal medicine), four titles supplied 56.5% of the articles and 27 titles supplied the other 43.5%. For Evidence-Based Medicine (general/family practice), five titles supplied 50.7% of the articles and 40 titles supplied the remaining 49.3%. For Evidence-Based Nursing (general practice nursing), seven titles supplied 51.0% of the articles and 34 additional titles supplied 49.0%. For Evidence-Based Mental Health (mental health), nine titles supplied 53.2% of the articles and 34 additional titles supplied 46.8%. For the disciplines of internal medicine, general/family practice, and mental health (but not general practice nursing), the number of clinically important articles was correlated withScience Citation Index (SCI) Impact Factors.
Conclusions
Although many clinical journals publish high-quality, clinically relevant and important original studies and systematic reviews, the articles for each discipline studied were concentrated in a small subset of journals. This subset varied according to healthcare discipline; however, many of the important articles for all disciplines in this study were published in broad-based healthcare journals rather than subspecialty or discipline-specific journals.
doi:10.1186/1741-7015-2-33
PMCID: PMC518974  PMID: 15350200
25.  Update on inflation of journal prices: medical journals, U.S. journals, and Brandon/Hill list journals. 
This paper examines the increases in prices for the last twenty years for the journals listed in the 1987 Brandon/Hill list and for the last twelve years for those on a list of medical and general periodicals published annually in Library Journal. This information is compared to the general U.S. inflation rate as measured by the Consumer Price Index. Despite the decline in the general rate of inflation, the buying power of libraries has continued to dwindle. Librarians need to use this information when justifying increased budget requests. They also need to interact more effectively with publishers to resolve this problem. The buying power of the dollar (as compared to the 1975 dollar) spent on the Brandon/Hill list journals is now 59% of that of a dollar spent in the general economy. This compares to 64% in 1983, when this research was last updated.
PMCID: PMC227304  PMID: 2720211

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