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An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients
Sponsor: Fudan University
Summary
Luteal phase deficiency (LPD) accounts for most failures of assistant artificial reproduction (ART) and early pregnancy loss for patients with idiopathic hypogonadotropic hypogonadism (IHH). Luteal phase support (LPS) is one of the indispensable interventions in ART treatments for IHH patients, which includes progestin, estrogen, human chorionic gonadotropin (hCG), and GnRH agonists (GnRHa). We aim to verify additional hCG injection 48 hours following routine hCG trigger and ovulation for LPS on the basis of supplementation of estrogen and dydrogesterone could improve clinical pregnancy rate, cumulative pregnancy rate, live birth rate and the prevalence of early pregnancy loss and ovarian hyperstimulation syndrome (OHSS) by an open labeled, prospective, and randomized clinical trial (RCT) in IHH patients in a single center.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2021-01-01
Completion Date
2025-12-31
Last Updated
2024-08-07
Healthy Volunteers
No
Interventions
Additional hCG injection
An additional hCG injection of 2000-5000IU would be given 48 hours following routine hCG trigger and ovulation for LPS on the basis of supplementation of estrogen and dydrogesterone.
estrogen and dydrogesterone
estrogen and dydrogesterone
Locations (2)
OB & GYN Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China