Objective: The study was conducted to examine several adjunct treatment regimens administered before and after embryo transfer and determine if one treatment was more efficacious than any of the alternative regimens on in vitro fertilization (IVF) outcome. We compared two different acupuncture stimulation modes, needle and laser acupuncture, with sham laser acupuncture, relaxation, or no intervention treatment on implantation and pregnancy rates in women undergoing IVF.
Design: Prospective single blind randomized trial.
Materials and Methods: Patients (n258) who had been scheduled for embryo transfer (ET), signed informed consent and were randomly assigned to one of 5 study treatment regimens; needle acupuncture (AC; 53), laser acupuncture (LZ AC; n53), sham laser acupuncture (placebo)(LZ sham; n52), relaxation (RX; n50), or no intervention treatment (NT; n50). All treatments were administered 25 minutes before ET and immediately after ET. The patient and acupuncturist were unaware of whether the laser system was active which allowed for a double-blind control group for the laser acupuncture treatment. Comparisons of various parameters between groups were conducted by 2 tests and one-way ANO- As.. Multinomial logistic regression analysis was used to control for the potentially confounding effects of day of embryo transfer (day 3 vs.5) and number of embryos transferred which are known to relate to IVF outcome, to further analyze the impact of adjunct treatment regimens on implantation and pregnancy rates. Probability of P 0.05 was considered to be statistically significant.
Results: No differences in terms of cycle type, day of embryo transfer, or physician performing transfer were found between treatment groups. Neither day of transfer (p0.079) or egg number (P 0.082) were significant independent redictors of implantation or conception when interactions between parameters were considered in all 5 groups. All acupuncture treatments were well tolerated.
Conclusion: Conception and implantation rates were highest with traditional needle acupuncture. IVF treatment outcomes did not differ between patients treated with laser or sham laser acupuncture. This study did not have the statistical power to detect treatment differences in pregnancy rates between needle acupuncture and no treatment (i.e., at least 200 subjects are needed to detect differences in CP rates of 54.7 and 44% with 80% power) which may be due to sample size, transfer of embryos of varying quality and variations in stimulation protocols. However, while not statistically significant, needle acupuncture produced a clinically significant effect (greater than 10% increase in clinical pregnancy rate) compared with relaxation or no treatment which warrants further investigation.