Discussion
macrosomia, congenital abnormalities
This prospective randomized clinical pilot trial investigated the effects of GnRH-a as an addition to progesterone luteal support on implantation, clinical pregnancy, and LBR. Another advantage of our study is data on the live birth and perinatal outcomes following the administration of single-dose GnRH-a in the luteal phase of AC-FET, including the rates of macrosomia and the congenital abnormalities of newborns. Recently, Ye et al. provided evidence demonstrating that GnRH-a administration in AC-FET cycles did not increase clinical or ongoing pregnancy. However, the result showed the implantation rate was significantly higher in 35~37 years old females with GnRH-a. They suggested that GnRH-a add-up could improve the implantation rate in the peri-implantation window in aging females (about 37 years old) GnRH-a plays a role in the treatment of LPS in fresh cycles. The recent meta-analysis, which includes 13 RCTs with 3,584 cycles, indicated that the females in IVF/ICSI (Intracytoplasmic Sperm Injection Cycles) received GnRH-a for luteal support had a significantly higher implantation rate and higher rates of pregnancy, clinical pregnancy, and live birth (In 2015, Davar et al. designed the first prospective randomized study on GnRH-a administration in AC-FET cycles including 200 patients. On the day of the embryo transfer, the patients in the GnRH-a group were given 0.1 mg triptorelin 3 days after ET. No statistically significant difference was observed between the GnRH-a group and the controls in terms of clinical and ongoing pregnancy rates (According to the previous studies, GnRHa seems not to have any benefit as an add-on in AC-FET cycles. Studies are mainly underpowered, and therefore larger studies in the future are needed. This pilot study was a prospective randomized trial with strict inclusion criteria. The sample size possibly accounted for the statistical interpretation of the results. There were few studies referenced when we planned to undertake this analysis. Limited research on the use of GnRHa administration during the luteal phase was conducted during fresh cycles. we could not conduct further larger-scale clinical trials before the efficacy and safety of the intervention were confirmed. We did not provide the power calculation because this study was designed as a pilot study. Post-study power analysis showed that the difference with 80% power in clinical pregnancy rate was statistical significance requiring a sample size of 194 patients per group. Nevertheless, our results may contribute to future meta-analyses. We are planning to carry out a further randomized controlled trial with a larger sample.