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GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

Sponsor
Mansoura University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02312089
Collaborator
(none)
200
Enrollment
2
Locations
2
Arms
75
Duration (Months)
100
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Gonadotropin Releasing Hormone Agonist for Luteal Phase Support in Gonadotropin Releasing Hormone Antagonist Protocol Cycles
Study Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Miscarriage rate [12 weeks gestational age]

      Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fertility Care Unit (FCU) in Mansoura University Hospital Mansourah Dakahlia Egypt 35111
    2 Private fertility care centers Mansourah Dakahlia Egypt

    Sponsors and Collaborators

    • Mansoura University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Sayed Abdelhafez, Dr, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT02312089
    Other Study ID Numbers:
    • MSA4
    First Posted:
    Dec 9, 2014
    Last Update Posted:
    Apr 28, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Mohamed Sayed Abdelhafez, Dr, Mansoura University
    Luteal phase support, ICSI, GnRHa
    Additional relevant MeSH terms:
    Infertility
    Triptorelin Pamoate

    Study Results

    No Results Posted as of Apr 28, 2020