An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients

Idiopathic Hypogonadotropic Hypogonadism Clinical Trial

— LPS-IHH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569577
• Other study ID #: FudanU2022-08-18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Fudan University
• Contact: Hexia Xia, M.D.
• Phone: +86 13601843476
• Email: hexia_xia[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hypogonadism
• Idiopathic Hypogonadotropic Hypogonadism
• Luteal Phase Support

Intervention

Drug:
• Additional hCG injection
An additional hCG injection of 2000-5000IU would be given 48 hours following routine hCG trigger and ovulation for LPS on the basis of supplementation of estrogen and dydrogesterone.
• estrogen and dydrogesterone
estrogen and dydrogesterone

Locations

Country	Name	City	State
China	OB & GYN Hospital of Fudan University	Shanghai	Shanghai
China	Obstetrics and Gynecology Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

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