Actively Recruiting
An Open-labeled Prospective Randomized Controlled Trial on the Effect of Different Regimens for Luteal Phase Support on Pregnancy Outcomes in Patients With Idiopathic Hypogonadotropic Hypogonadism
Led by Fudan University · Updated on 2024-08-07
46
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
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, women's 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.
CONDITIONS
Brief Title
An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of idiopathic hypogonadotropic hypogonadism (IHH) with primary amenorrhea or relevant hormone levels and normal hypothalamus and pituitary MRI
- Women of childbearing age who want to become pregnant
You will not qualify if you...
- Premature ovarian insufficiency or premature ovarian failure
- Primary amenorrhea caused by hypothalamic or pituitary lesions
- Secondary amenorrhea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive luteal phase support with estrogen and dydrogesterone, with some receiving an additional hCG injection 48 hours after routine hCG trigger and ovulation.
Weekly visits for up to 12 weeks
Duration - Up to 42 weeks or beyond
Participants are monitored for pregnancy outcomes, early pregnancy loss, and ovarian hyperstimulation syndrome.
Visits at 7 weeks, 12 weeks, and 42 weeks or beyond
Trial Site Locations
Total: 2 locations
1
OB & GYN Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
2
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
H
Hexia Xia, M.D.
W
Wei Zhang, Ph.D.,M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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