GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

October 27, 2023 updated by: Mohamed Sayed Abdelhafez, Mansoura University

Gonadotropin Releasing Hormone Agonist for Luteal Phase Support in Gonadotropin Releasing Hormone Antagonist Protocol Cycles

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia
      • Mansourah, Dakahlia, Egypt
        • Recruiting
        • Private fertility care centers
      • Mansourah, Dakahlia, Egypt, 35111
        • Recruiting
        • Fertility Care Unit (FCU) in Mansoura University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GnRHa group
Luteal phase SC administration of a single dose (0.2 mg) of GnRHa (Triptorelin)
Drug: Triptorelin
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
Other Names:
  • Decapeptyl
No Intervention: Control group
No GnRHa administration in luteal phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 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
6 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 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
6 weeks after embryo transfer
Miscarriage rate
Time Frame: 12 weeks gestational age
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
12 weeks gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Waleed El-refaie, Dr, Port Said University
  • Principal Investigator: Mohamed S Abdelhafez, Dr, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2016

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimated)

December 9, 2014

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSA4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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