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

NCT05569577 | Recruiting

• 1 other identifier: FudanU2022-08-18
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Luteal Phase Deficiency; Luteal Phase Support; Idiopathic Hypogonadotropic Hypogonadism

Keywords

Luteal phase deficiency; Idiopathic hypogonadotropic hypogonadism

Outcome Measures

Primary Outcomes (3)

• Clinical pregnancy rate

  Defined as the presence of a gestational sac under ultrasonography

  7 weeks

• Cumulative pregnancy rate

  Defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.

  12 weeks

• 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 Outcomes (2)

• Number of IHH patients ending in early pregnancy loss

  12 weeks

• Number of IHH patients with ovarian hyperstimulation syndrome

  12 weeks or beyond

Other Outcomes (1)

• Serum progesterone levels on Day 1, 7, and 14 after ovulation

  7 weeks

Study Arms (2)

Additional hCG injection

EXPERIMENTAL

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.

Drug: Additional hCG injection; Drug: estrogen and dydrogesterone

No additional hCG injection

PLACEBO COMPARATOR

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

Drug: estrogen and dydrogesterone

Interventions

Additional hCG injection 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.

Additional hCG injection

estrogen and dydrogesterone DRUG

estrogen and dydrogesterone

Additional hCG injection; No additional hCG injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women aged between 18-45 years is reproductive. IHH patients in the age have willings to get pregnant and they would seek helps in outpatient clinic of Gynecological endocrinology.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Premature ovarian insufficiency or premature ovarian failure
• Primary amenorrhea due to hypothalamic/pituitary lesions
• Secondary amenorrhea

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

OB & GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Interventions

Estrogens; Dydrogesterone

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Wei Zhang, Ph.D.,M.D.

  GCP office

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hexia Xia, M.D.

CONTACT

+86 13601843476; hexia_xia@fudan.edu.cn

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

CONTACT

+86 13611691036; zhangwei623@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In the current study, none of patients, investigators and designers is marked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We have two cohorts in the current study and patients are randomly assigned to either cohort of additional hCG injection or not.

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 6, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)