Can we alter pregnancy outcome by adjusting progesterone treatment at mid-luteal phase: a randomized controlled trial

Abstract

Our study aimed to determine whether mid-luteal serum P concentrations can serve as a predictive factor for in vitro fertilization (IVF) outcomes and whether increasing P dosage for patients with low levels at mid-luteal phase may improve pregnancy rates. It was a prospective, randomized controlled study. A total of 146 patients undergoing IVF treatment were prospectively enrolled and received routine luteal phase support (LPS) regimen of Endometrin® (progesterone) 200 mg/day. Serum P levels were measured 7 days after embryo transfer (ET). Considering a cutoff level of 15 ng/ml on this day, patients with higher levels continued the same dosage until pregnancy test (control group). Patients with lower levels were randomly allocated to continue Endometrin® 200 mg/day (Group A) or to increase Endometrin® dosage to 300 mg/day (Group B). The Main Outcome Measures were pregnancy rates. Both biochemical and clinical pregnancy and live birth rates were comparable between all groups regardless of P level on day 7 of luteal phase and regardless of dose adjustment. ROC analysis determined that mid-luteal P levels of 17 ng/ml can be a better predictor of cycle outcome. In conclusion raising the P dose at mid-luteal phase to 300 mg daily did not improve cycle outcomes.

Chinese abstract

我们的研究旨在确定黄体中期血清P浓度是否可以作为体外受精（IVF）结果的预测因素, 以及是否提高黄体中期P低水平患者的P剂量可能会提高妊娠率。这是一项前瞻性随机对照研究。共有146例接受IVF治疗的患者前瞻性地入组, 并接受了200mg/天孕酮的常规黄体期支持（LPS）方案。在胚胎移植（ET）7天后测量血清P水平。考虑到这一天的临界值为15ng/ml, 具有较高水平的患者持续相同的剂量直至妊娠试验（对照组）。低水平的患者随机分配为200 mg/d孕酮（A组）和将孕酮剂量增加至300 mg/d（B组）。主要结局监测指标为妊娠率。无论黄体期第7天P水平如何, 无论孕酮剂量, 生化和临床妊娠、活产率在所有组之间是可比的, ROC分析确定黄体中期17ng/ml的P值可以更好地预测周期结果。总之, 将黄体中期的P剂量提高到每日300mg并没有改善周期结果。

Keywords:

• ART
• luteal phase support
• prediction of pregnancy
• progesterone

Declaration of interest

The authors report no conflicts of interest.

Ethic approval

Institutional review board approval was obtained and all the patients provided signed informed consent in order to participate in the study.

The NIH clinical trials registration number is NCT01356524.