The effects of low-dose human chorionic gonadotropin for luteal phase support on pregnancy outcomes in poor ovarian responders: a randomized clinical trial

Purpose: The question that remains is, does changing the type of luteal phase support (LPS) improve the pregnancy outcomes in patients with poor ovarian response (POR) diagnosis?. Therefore, this study was designed to investigate and compare the efficiency of different methods of luteal phase support (progesterone alone or hCG alone and the combination of progesterone with hCG) in these patients.Methods: This randomized clinical trial evaluated three hundred seventy five patients who were diagnosed as POR on the basis of Bologna criteria undergoing intracytoplasmic sperm injection- embryo transfer (ICSI-ET) cycles at Royan institute from November 2015 to June 2019. The patients were allocated randomly into three different LPS groups on the day of oocyte pickup. In first group, 1500 IU of hCG IM on the ET day, as well as 4 days after that were administrated. 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 suppositories 400 mg twice daily. For the third group, only vaginal suppositories twice daily was administrated from the day of oocyte pick up until the pregnancy test day.The clinical pregnancy, miscarriage and live birth rates were the main outcomes. Results: The data analysis showed that the three groups were comparable. In the following, there is no significant difference in terms of implantation, clinical pregnancy, and miscarriage and live birth rates among groups. The twin pregnancy rate in the hCG-only group was higher than those of in the other two groups, although this difference was not statistically significant (P=0.06).Conclusion: The type of LPS does not improve the pregnancy and live birth rates in POR patients. A multi-center clinical trial is warranted to confirm or refute these findings.Trial registration: The study was registered in the clinicaltrial.gov site on 14 June 2015. (NCT02798653 at www. clinicaltrials.gov, registered prospectively).

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