Clinical trial NCT05569577: An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Luteal Phase Deficiency
Luteal Phase Support
Idiopathic Hypogonadotropic Hypogonadism
Keywords: Luteal phase deficiency
Idiopathic hypogonadotropic hypogonadism
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We have two cohorts in the current study and patients are randomly assigned to either cohort of additional hCG injection or not.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Idiopathic hypogonadotropic hypogonadism (IHH) is a congenital disease caused by a variety of gene variants leading to dysfunction in the secretion of hypothalamic gonadotropin-releasing hormones (GnRHs), with a prevalence of 1:125 000 in females. Girls with IHH often suffer from lack of puberty onset, amenorrhea and infertility, complicated with psychological problems such as depression and anxiety, due to delayed diagnosis and inappropriate treatment. Luteal phase deficiency (LPD) accounts for most failures of assistant artificial reproduction (ART) and early pregnancy loss for IHH patients. We have reported a severe LPD during the early trimester in a case with secondary HH following craniopharyngioma resection and speculated similar LPD happen in IHH patients complicated with low clinical pregnancy rate and live birth rate. Therefore, 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 of the Obstetrics and Gynecology Hospital Affiliated to Fudan University. The onset of patients' mental and psychological diseases such as depression and anxiety rely on their reproductive needs and pregnancy outcomes, which will also be investigated in the current study. Moreover, the effect of clinical interventions to improve pregnancy outcomes and emotional disorders would be discussed.

Eligibility 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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 7 weeks
measure: Cumulative pregnancy rate
timeFrame: 12 weeks
measure: Live birth rate
timeFrame: 42 weeks or beyond
Secondary outcomes:
measure: Number of IHH patients ending in early pregnancy loss
timeFrame: 12 weeks
measure: Number of IHH patients with ovarian hyperstimulation syndrome
timeFrame: 12 weeks or beyond
Other outcomes:
measure: Serum progesterone levels on Day 1, 7, and 14 after ovulation
timeFrame: 7 weeks
Locations:
city: Shanghai
country: China
facility: OB & GYN Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: GCP office
name: Wei Zhang, Ph.D.,M.D.
role: PRINCIPAL_INVESTIGATOR
References: