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

NCT ID: NCT05569577

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Luteal Phase Deficiency; Luteal Phase Support; Idiopathic Hypogonadotropic Hypogonadism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Additional hCG injection

An additional hCG injection of 2000-5000IU would be performed 48 hours following routine hCG trigger on the basis of supplementation of estrogen and dydrogesterone in IHH patients.

Group Type: EXPERIMENTAL

Additional hCG injection

Intervention Type: DRUG

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

Intervention Type: DRUG

estrogen and dydrogesterone

No additional hCG injection

Only estrogen and dydrogesterone would be given for luteal phase support in IHH patients.

Group Type: PLACEBO_COMPARATOR

estrogen and dydrogesterone

Intervention Type: DRUG

estrogen and dydrogesterone

Interventions

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.

Intervention Type: DRUG

estrogen and dydrogesterone

estrogen and dydrogesterone

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhang Wei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Zhang, Ph.D.,M.D.

Role: PRINCIPAL_INVESTIGATOR

GCP office

Locations

OB & GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hexia Xia, M.D.

Role: CONTACT

hexia_xia@fudan.edu.cn

+86 13601843476

Wei Zhang, Ph.D.,M.D.

Role: CONTACT

zhangwei623@hotmail.com

+86 13611691036

Facility Contacts

Hexia Xia, Doctor

Role: primary

hexia_xia@fudan.edu.cn

13601843476

Wei Zhang, PhD

Role: primary

zhangwei623@hotmail.com

+86 13611691036

Other Identifiers

FudanU2022-08-18

Identifier Type: -

Identifier Source: org_study_id