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

Inclusion Criteria2

  • 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

Exclusion Criteria3

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

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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