The Effects of Three Methods of Luteal Phase Support on Pregnancy Outcomes in Poor Ovarian Responders: A Randomized Clinical Trial.

Abstract

Background: The effectiveness of changing the type of luteal phase support in patients with poor ovarian response (POR) remains unclear based on the available evidence. This study aimed to compare the effectiveness of various luteal phase support (LPS) methods, including progesterone alone, human chorionic gonadotropin (hCG) alone, and the combination of progesterone with hCG, in these patients.

Materials and methods: In this randomized clinical trial, 375 patients diagnosed with POR based on the Bologna criteria underwent intracytoplasmic sperm injection-embryo transfer (ET) cycles at the Royan Institute between November 2015 and June 2019. The patients were allocated randomly into three different LPS groups on the day of oocyte pickup. In the first group, 1500 IU of hCG on the ET day, as well as 4 days after that were administrated intramuscularly. In the second group, the patients received 1500 IU of hCG IM on the ET day, as well as 3 and 6 days after the ET along with vaginal progesterone suppositories of 400 mg twice daily. For the third group, only vaginal suppositories twice daily were administrated from the day of oocyte pick up until the pregnancy test day. The clinical pregnancy, miscarriage and live birth rates were compared among groups using appropriate statistical tests.

Results: The data analysis indicated that the three groups were comparable, and there were no significant differences among the groups in terms of implantation, clinical pregnancy, miscarriage, and live birth rates. The twin pregnancy rate in the hCG-only group was higher than in the other two groups, although this difference did not reach statistical significance (P=0.060).

Conclusion: Similar pregnancy and live birth rates were observed among different LPS regimens. Interestingly, the use of two boluses of low-dose hCG (1500) was associated with a slight increase in multiple pregnancies. We suggest this effective method, which is easier and more patient-friendly (registration number: NCT02798653).