Overview

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

Status:
Recruiting

Trial end date:
2025-12-31

Target enrollment:
0

Participant gender:
Female

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fudan University

Treatments:

Dydrogesterone
Estrogens

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