Typical Western treatments for infertility include medication (hormone stimulation), surgical correction of anatomical defects, or artificial insemination. For couples who do not benefit from these treatments, the remaining options include gamete intrafallopian transfer, intracytoplasmic sperm injection, in vitro fertilization, and zygote intrafallopian transfer. Although all of these therapies can be successful, they are often expensive, invasive, and time consuming. With the introduction and integration of Eastern medicine into Western practices, there has been an increase in the acceptance and use of complementary practices in dealing with infertility.^4,5 The anxiety and depression that are often associated with infertility has made alternative and combination therapies a realistic and beneficial option for those faced with varied types of infertility. Any noninvasive, non-time-consuming, and cost-effective manner of alternative therapies can also be viewed as a patient benefit. The now common use of acupuncture has proven effective for endocrine stimulatory and regulatory interventions.⁶

While conventional treatment options are well established, there have been few systematic reviews of CAM approaches for the treatment of infertility.⁷ Several studies have reported the use of acupuncture as a treatment for various gynecologic conditions,⁸ while others have reported case studies on the use of Traditional Chinese Medicine (including herbs and acupuncture) for treating infertility.^9,10 While the proponents of these therapies value their safety, minimally invasive approaches, and minimal side-effects, there have not been thorough reviews or studies to assess the effectiveness of traditional approaches for treating infertility. Bridging the gap in knowledge and practice between Western and Eastern medicine as well as looking at how medicine is practiced in under studied medical systems¹¹ are important issues in the fertility field.

Inclusion criteria for study participation included all of the following: unexplained infertility confirmed with laparoscopy and ultrasonography, regular menstrual cycle of 25–35 days, no infertility factor in their male partner, clear communication skills with hospital researchers, and normal hormonal test result range. If all of the inclusion criteria were verified within the 12 months prior to initiation of participation, women were included. Women were excluded from the study when the inclusion criteria were not met, or if hormone supplementation (including clomiphene citrate¹³), in vitro fertilization or intrauterine insemination treatments were undertaken during the 6-month study period. Those women with minimal/mild endometriosis were included in the study, as were women over the age of 35 (age typically classified as the cutoff for high-risk pregnancies to develop).

The flow of the study is shown in Figure 1. The number of patients remaining in or achieving pregnancy throughout the entire study period of 6 months was 23 (14 pregnancies), or 22.1%. Slightly more than half (n=55) dropped out before reporting their third menstruation cycle. The trend of dropout was high in the early stage and gradually decreased. Out of 14 pregnancies, there were 10 normal births, 4 miscarriages, and no stillbirth. Otherwise, there was no neonatal morbidity/mortality. Total monthly cost for the treatment package was about $500.

Six (6) participants (5.8%) reported minor adverse events including rash in the face (n=1), diarrhea (n=2), dizziness (n=1), and heartburn (n=2). All of the symptoms were mild, and eased after patients stopped taking the specific herbal medicine; no hospitalization was required. Figure 2 shows reasons stated for individual dropouts. The most frequently cited reason was “personal reasons,” which may be a polite way of expressing difficulty or unwillingness to afford this treatment ($500/month).

The outcomes that were obtained in the group that completed the study as well as those that dropped out are significant. Although the success for achieving pregnancy is downplayed by the number of dropouts in the study, if more than 22.1% of the initial subject group had followed through until the end, the outcomes might have provided a strong call for the implementation of noninvasive Eastern medical practices to be more than an adjuvant therapy for infertility. Although completion rates for observational studies on infertility may range as high as 90% in studies that involve a stipend,¹⁴ it is our understanding that our completion rate of 22.1% in an observational study (which should be markedly less than any designed cohort or case–control study) that asked for a capitation payment from the subjects was acceptable. In contrast to studies where treatments were provided free of charge, in this observational study participants had to pay for their individual treatment. The personal reasons for dropping out could also include unreported illness, emotional or psychologic burden, and loss of interest, which the investigators regret we did not classify in detail. The movement of patients out of the area as well as the desire to seek other treatment options, and administrative issues in contacting participants accounted for the remainder of patients who did not complete the treatment course.

It is important to understand the complex array of effects that play into the seeking out of and adherence to treatment in regard to fertility. In the realm of unexplained in fertility, especially where patients have no pointed abnormality with hormone levels, or physical impediments that have been diagnosed, the emotional and psychologic toll is overarching. To achieve success and completion with the standard package of care in this difficult situation is promising. One interesting point to interpret in future study results will be to look at the demographic composition of women who did complete the treatment. As such a large percentage of dropouts stated that “personal reasons” were the impetus for lack of completion, it brings forth the question, why did personal reasons not get in the way of adherence for those women who completed treatment? Is this group older and therefore more prone to follow through without regard to time constraints or economic detriment? Is this group more inclined to participate in this traditional and noninvasive type of care in other aspects of their lives? Or simply, does this group live closer or have substantial economic means to achieve the final outcome of visiting for a combined six menstrual periods? In addition, are women in this group more desperate for conception than the others?

As we look at previous studies of traditional care for infertility, there is insufficient literature looking at Korean medical practices and their influence on infertility. Much of the current literature on traditional medicine and infertility deals with male infertility, includes the use of medical procedures in conjunction to Eastern medicine,⁷ or comes from Indian or Chinese researchers who use similar but decisively different methods from those of this study. These alternatives include the use of numerous similar yet different herbs, but exclude the use of acupuncture and herbal pills. Therefore, research in this area is to an extent novel and in its own right a worthwhile endeavor.

The use of traditional Korean medicine has become very appealing to patients as a primary or adjuvant therapeutic tool. The mixed results reported by many researchers in regard to fertility-related outcomes can be explained by the standardization of treatments and therefore lack of personalized care plans.^15,16 While further discussion of the individual treatments included in the package is beyond the scope of this study, there may certainly be a benefit to this method of treatment.

This observational study into unexplained infertility treatment would further benefit from work done in the following aspects: (1) investigating the outcomes of consecutive treatment in contrast to a cumulative treatment over a number of months on the success of pregnancy and other symptoms of menstruation; (2) studying detailed categories of reasons for the discontinuation of treatments, including cost and confidence in the treatment; (3) carrying out matched comparative studies on women with unexplained infertility who did not use the standard therapeutic package from Conmaul Hospital versus women who did (introduction of a specific control); (4) investigating outcomes of the standard care package for this unexplained infertility in regard to general health and wellness. What other benefits or detriments can be associated with the package, as most herbal therapeutic packages have extensive effects; (5) looking at distinct groups of women younger than and older than 35, the age commonly designated as when pregnancies become high risk, and the possible difference in treatment outcomes; and (6) performing a similar study with free treatment. Through looking at women who are not self-selected based upon access to hospital care (through economic and motivational means), a better understanding of the population-level effectiveness of CAM fertility package therapy as a whole could be understood.

Upon completion of this study, the limitations of an observational study in the Conmaul Hospital were typified by the relatively low adherence rate of participants. At the same time, the success rate of the standard therapeutic package for treatment of unexplained infertility was strengthened. Overall, whether or not pregnancy was achieved, and whether or not participants finished treatment, or infertility persisted, the multiple psychologic and physiologic problems associated with unexplained infertility were studied and provided a baseline for future research on this meaningful complementary subject field.