Effect of extra hCG injection on pregnancy outcomes in women with idiopathic hypogonadotropic hypogonadism
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
This study is testing if an extra hCG injection can help women with a hormone condition get pregnant more successfully when they use assisted reproductive technology.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT05569577 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of an additional human chorionic gonadotropin (hCG) injection on pregnancy outcomes for women diagnosed with idiopathic hypogonadotropic hypogonadism (IHH) who are undergoing assisted reproductive technology (ART). The study aims to determine if administering hCG 48 hours after the standard hCG trigger, alongside estrogen and dydrogesterone supplementation, can enhance clinical pregnancy rates, cumulative pregnancy rates, live birth rates, and reduce early pregnancy loss and ovarian hyperstimulation syndrome (OHSS). It is a prospective, open-labeled, randomized trial conducted at a single center, focusing on women of childbearing age who wish to conceive.
Who should consider this trial
Good fit: Ideal candidates for this study are women of childbearing age diagnosed with idiopathic hypogonadotropic hypogonadism who desire to become pregnant.
Not a fit: Patients with premature ovarian insufficiency or those whose amenorrhea is due to hypothalamic or pituitary lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pregnancy outcomes for women with IHH undergoing ART.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in improving pregnancy outcomes with luteal phase support in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Premature ovarian insufficiency or premature ovarian failure * Primary amenorrhea due to hypothalamic/pituitary lesions * Secondary amenorrhea
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- OB & GYN Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Obstetrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wei Zhang, Ph.D.,M.D. — GCP office
- Study coordinator: Hexia Xia, M.D.
- Email: hexia_xia@fudan.edu.cn
- Phone: +86 13601843476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.