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

Recruiting now · Not applicable

Conditions studied: Luteal Phase Deficiency, Luteal Phase Support, Idiopathic Hypogonadotropic Hypogonadism

In brief

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.

Key facts

Study ID: NCT05569577
Run by: Fudan University
People needed: 46
Starts: 2021-01-01
Expected to finish: 2025-12-31
Last updated by the study team: 2024-08-07

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Clinical diagnosis of IHH (primary amenorrhea (with or without a history of hormone supplementation therapy); basic LH levels <5IU/L, FSH<5IU/L or normal; no organic lesions in the hypothalamus and pituitary MRI).
Women of childbearing age who desire to get pregnant

You may not qualify if…

Premature ovarian insufficiency or premature ovarian failure
Primary amenorrhea due to hypothalamic/pituitary lesions
Secondary amenorrhea

Where it is running

OB & GYN Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
Obstetrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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