The addition of single dose GnRH agonist to luteal phase support in artificial cycle frozen embryo transfer: a randomized clinical trial

Abstract

This prospective randomized clinical trial (RCT) was to evaluate the effect of single-dose gonadotrophin-releasing hormone agonist (GnRHa) in artificial cycle frozen-embryo transfer (AC-FET). A total of 868 FET cycles were included and randomized into two groups: Group A (n = 434) received GnRHa 0.1 mg subcutaneous injection on day 3 after embryo transfer (ET); Group B (n = 434) did not receive GnRHa. The demographic characteristics, primary endpoint (implantation rate) and secondary endpoints (chemical pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate) were compared between two groups and subgroups (aged <35 years and 35-37 years). There were no significant differences in terms of the rates of implantation, clinical pregnancy, ongoing pregnancy, and miscarriage between two groups. While, the subgroups analysis showed the implantation rate was significantly increased in advanced age women (35–37 years) in GnRHa group compared with control group (45.3% vs. 27.8%, p = .03). In conclusion, single dose of GnRHa (0.1 mg triptorelin acetate) supplementation 3 days after ET in AC-FET cycles did not show significant benefit on pregnancy outcomes as a whole. However, in ageing women subgroup, the implantation rate was increasing by adding up GnRHa in peri-implantation periods, and this tendency needs to be further demonstrated by RCT with larger sample size.

Trial registration: ClinicalTrials.gov identifier: NCT02655146.

Abstract

此前瞻性随机临床试验(RCT)旨在评价单剂量促性腺激素释放激素激动剂(GnRHa)在人工周期冷冻胚胎移植(AC-FET)中的作用。共纳入868个FET周期, 随机分为两组：A组(n = 434)胚胎移植后第3天皮下注射GnRHa 0.1mg (ET)；B组(n = 434)不用GnRHa。比较两组和亚组(年龄<35岁和35-37岁)间的人口学特征、主要终点(植入率)和次要终点(生化妊娠率、临床妊娠率、持续妊娠率)。两组在植入率、临床妊娠率、持续妊娠率和流产率方面无显著差异。亚组分析显示, GnRHa组中高龄女性的(35-37岁)植入率明显高于对照组(45.3% vs. 27.8%, p=.03)。 综上所述, 在AC-FET周期中, ET后3天应用单剂量GnRHa (0.1mg醋酸曲普瑞林)对整体妊娠结局未显示出明显受益。然而, 在高龄妇女亚组中, 着床期应用GnRHa可使植入率提高, 这一趋势还需要更大样本量的RCT研究进一步证实。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• Artificial cycle
• frozen embryo transfer
• luteal phase support
• GnRH agonist
• implantation rate

Disclosure statement

No potential conflict of interest was reported by the authors.