A Randomized Trial Comparing Additional hCG Injection Versus Standard Luteal Phase Support to Improve Pregnancy Outcomes in Women With Idiopathic Hypogonadotropic Hypogonadism

What this Trial Is About

This research aims to evaluate the effects of additional human chorionic gonadotropin hCG injections for luteal phase support LPS on pregnancy outcomes in women with idiopathic hypogonadotropic hypogonadism IHH. IHH is a rare condition caused by genetic variants leading to hormone secretion issues, resulting in delayed puberty, amenorrhea, infertility, and psychological challenges. Luteal phase deficiency LPD is a major cause of failure in assisted reproductive treatments and early pregnancy loss in these patients. This open-labeled, prospective, randomized clinical trial conducted in a single center investigates whether an extra hCG injection 48 hours after the routine trigger can improve pregnancy success rates and reduce complications like early pregnancy loss and ovarian hyperstimulation syndrome OHSS. Participants are randomly assigned to one of two groups one receives an additional hCG injection of 2000-5000 IU 48 hours after the routine hCG trigger and ovulation, alongside estrogen and dydrogesterone supplementation for luteal phase support. The other group receives only estrogen and dydrogesterone. The trial compares clinical pregnancy rate at 7 weeks, cumulative pregnancy rate at 12 weeks, and live birth rate at 42 weeks or beyond to assess the impact of the added hCG. During the study, womens reproductive and psychological health will be monitored, including pregnancy outcomes and mental health conditions such as depression and anxiety linked to reproductive needs. Researchers will track early pregnancy loss and OHSS occurrences. Participants will be followed through pregnancy milestones, with the total study duration covering up to the live birth period, allowing comprehensive evaluation of treatment effects and associated emotional outcomes.

An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients