A randomized controlled trial of vaginal progesterone for luteal phase support in modified natural cycle – frozen embryo transfer

Abstract

Objective

Our aim was to study whether luteal phase support (LPS) increases the live-birth rate (LBR) in women undergoing modified natural cycle (mNC) frozen-thawed embryo transfer (FET).

Methods

In a randomized controlled trial, conducted at a university-affiliated tertiary medical center, a total of 59 patients aged 18–45 years, underwent mNC-FET. FET was performed in mNC following ovulation triggering by hCG. Patients were randomized into two groups; The No-LPS Group included 28 women who did not receive LPS, and the LPS Group included 31 women who received vaginal progesterone for LPS. The main outcome measure was LBR.

Results

Baseline demographic and clinical characteristics were comparable between the study groups. The no-LPS group and the LPS group did not differ with regard to clinical pregnancy rate (21.4% vs. 32.3%; respectively, p = .35), LBR (17.9% vs. 19.4%; respectively, p = .88), or spontaneous miscarriage rate (3.6% vs. 12.9%; respectively, p = .35). On multivariate logistic regression analysis, LPS was not associated with LBR after controlling for confounders.

Conclusion

The results of our study suggest that LPS after mNC-FET does not improve the reproductive outcome, and therefore, might not be necessary.C linicaltrials.gov identifier: NCT01483365.

阴道孕酮在改良自然周期冷冻胚胎移植中黄体期支持的随机对照试验 摘要

目的：我们的目的是研究黄体期支持(LPS)是否能增加接受改良自然周期(mNC)冻融胚胎移植(FET)女性的活产率(LBR)。

方法：在某大学附属三级医院进行的随机对照试验中, 共59例18-45岁的患者接受了mNC-FET治疗。在hCG触发排卵后的mNC行FET。患者随机分为两组;无LPS组纳入了28名未接受LPS治疗的女性, LPS组包括31名接受阴道孕激素治疗的女性。主要的测量结果是LBR。

结果：基线人口统计学和临床特征在各个研究组之间具有可比性。无LPS组与LPS组临床妊娠率无显著差异(分别21.4% vs. 32.3%；p=.35)、LBR (分别为17.9% vs. 19.4%；p=.88), 或自然流产率(分别3.6% vs. 12.9%；p = .35)。在多因素logistic回归分析中, 在控制混杂因素后, LPS与LBR无相关性。

结论：我们的研究结果表明, mNC-FET后LPS不能改善生殖结果, 因此可能没有必要

Keywords:

• Frozen embryo transfer
• ART
• luteal phase support
• modified natural cycle
• RCT

Disclosure statement

No potential conflict of interest was reported by the author(s).