Objective: To develop a protocol that could be used in future studies to evaluate whether acupuncture improves pregnancy and delivery rates in patients undergoing IVF. DESIGN: Randomized, sham treatment controlled pilot study.
Materials and Methods: Patients planning to undergo IVF who meet inclusion/exclusion criteria (age 40 years old at start of stimulation, highest basal FSH 10mIU/mL, 3 prior failed IVF attempts, acupuncture naıeve) were randomly assigned to an acupuncture treatment group or a sham treatment group.
Treatment sessions occurred before the start of gonadotropin stimulation, the day before the oocyte retrieval, the day before the embryo transfer and the day after the embryo transfer. Acupuncture was performed using manual manipulation at 6 to 10 points depending on the timing of the acupuncture treatment. Sham treated patients had needles placed in non meridian points at a shallow depth. Patients were also given a questionnaire regarding their impressions of acupuncture treatment and were asked to guess their group assignment.
Data was analyzed using chi-squared for dichotomous outcome variables (e.g. clinical pregnancy rate, number of take home babies) and t-tests for continuous outcomes (e.g. age).
Results: Twenty-two IVF cycles (19 patients) were randomized with thirteen patients completing the study (14 cycles). Five cycles were not completed due to poor response to ovarian stimulation (4 in the sham group,one in the real group). Other reasons for incomplete cycles (all in the sham group) included a persistent ovarian cyst, no viable embryos for transfer and personal reasons. The overall cycle cancellation rate was 32% compared to a 22% cycle cancellation rate for non study patients of a similar age treated at this center during a similar time period (p.05).
In the 13 patients analyzed, the mean age was 35 years old (SD4.03). There was no statistical difference between true and sham acupuncture groups with respect to age (Sham: Mean35, SD4.6, Real: Mean34, SD4.6). Additionally, there was no significant difference between groups in highest basal FSH, number of oocytes retrieved, or number of embryos transferred. There was a significantly higher chemical pregnancy rate (80% versus 11.0%) in patients receiving true acupuncture compared to sham acupuncture (p.05). The clinical pregnancy rates and the take home baby rates showed a strong trend towards a higher rate with acupuncture treatment though the difference was not statistically significant (60% real treatment vs. 11% sham treatment, p.05.).
Regarding the questionnaire, only one patient correctly guessed their group assignment (real acupuncture). All patients rated their experience as very positive or positive.
Conclusion: It is feasible to conduct a randomized, blinded, sham control trial to study the impact of acupuncture on IVF success rates. Such a protocol is well accepted by patients. Preliminary data shows a statistically significant improvement in the biochemical pregnancy rate with acupuncture treatment. Additionally, acupuncture was associated with a strong trend towards higher clinical pregnancy rates and take home baby rates, though more patients will need to be studied to reach any final conclusions.