GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

Phase 4

Recruiting

• Conditions: Infertility
• Interventions: Drug: Triptorelin

• Registration Number: NCT02312089
• Lead Sponsor: Mansoura University

Brief Summary

Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following GnRH antagonist protocol

Detailed Description

Endometrial preparation for embryo transfer (ET) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. The patients will be randomly divided into 2 groups for luteal phase support: (i) Group A (GnRHa group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval, and (ii) Group B (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after ET

Study Timeline

• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-09
• Study Start: 2016-08-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.

Exclusion Criteria

• Moderate or severe endometriosis.
• Hydrosalpinx.
• Uterine abnormalities.
• Myoma.
• Previous uterine surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRHa group	Triptorelin	Luteal phase SC administration of a single dose (0.2 mg) of GnRHa (Triptorelin)

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6 weeks after embryo transfer	Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures

Secondary Outcome Measures

Name	Time	Method
Implantation rate	6 weeks after embryo transfer	Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos
Miscarriage rate	12 weeks gestational age	Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

Trial Locations

Locations (2)

Fertility Care Unit (FCU) in Mansoura University Hospital; 🇪🇬 Mansourah, Dakahlia, Egypt

Private fertility care centers; 🇪🇬 Mansourah, Dakahlia, Egypt