Idiopathic Hypogonadotropic Hypogonadism Clinical Trial
— LPS-IHHOfficial title:
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
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | OB & GYN Hospital of Fudan University | Shanghai | Shanghai |
China | Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Serum progesterone levels on Day 1, 7, and 14 after ovulation | Serum progesterone levels is a symbol of luteal function | 7 weeks | |
Primary | Clinical pregnancy rate | Defined as the presence of a gestational sac under ultrasonography | 7 weeks | |
Primary | Cumulative pregnancy rate | Defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond. | 12 weeks | |
Primary | Live birth rate | Defined as the number of deliveries that resulted in a live born neonate, expressed per 100 pregnancies. | 42 weeks or beyond | |
Secondary | Number of IHH patients ending in early pregnancy loss | Early pregnancy loss is defined as the loss of a pregnancy prior to 12 weeks gestation | 12 weeks | |
Secondary | Number of IHH patients with ovarian hyperstimulation syndrome | Ovarian hyperstimulation syndrome is defined as an exaggerated response to excess hormones. It usually occurs in women taking injectable hormone medications to stimulate the development of eggs in the ovaries. Ovarian hyperstimulation syndrome (OHSS) causes the ovaries to swell and become painful. | 12 weeks or beyond |
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