Actively Recruiting
An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients
Led by Fudan University · Updated on 2024-08-07
46
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of idiopathic hypogonadotropic hypogonadism (IHH) confirmed by primary amenorrhea with or without hormone therapy history, low or normal LH and FSH levels, and no hypothalamus or pituitary lesions on MRI
- Women of childbearing age who want to get pregnant
You will not qualify if you...
- Premature ovarian insufficiency or premature ovarian failure
- Primary amenorrhea caused by hypothalamic or pituitary lesions
- Secondary amenorrhea
AI-Screening
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Trial Site Locations
Total: 2 locations
1
OB & GYN Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
2
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
H
Hexia Xia, M.D.
CONTACT
W
Wei Zhang, Ph.D.,M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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