RecruitingNot ApplicableNCT05569577

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

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


Sponsor

Fudan University

Enrollment

46 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Additional hCG injection and a drug called estrogen and dydrogesterone for people with idiopathic hypogonadotropic hypogonadism, luteal phase deficiency, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdditional 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.

DRUGestrogen 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

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NCT05569577