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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
OB & GYN Hospital of Fudan University
RECRUITING
Shanghai
Obstetrics and Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Hexia Xia, M.D.
hexia_xia@fudan.edu.cn
+86 13601843476
Backup
Wei Zhang, Ph.D.,M.D.
zhangwei623@hotmail.com
+86 13611691036
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 46
Treatments
Experimental: Additional hCG injection
An additional hCG injection of 2000-5000IU would be performed 48 hours following routine hCG trigger on the basis of supplementation of estrogen and dydrogesterone in IHH patients.
Placebo_comparator: No additional hCG injection
Only estrogen and dydrogesterone would be given for luteal phase support in IHH patients.
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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