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Antagonist Protocol in IVF

Sponsor
Woman's Health University Hospital, Egypt (Other)
Overall Status
Unknown status
CT.gov ID
NCT02335736
Collaborator
Cairo University (Other)
200
Enrollment
1
Location
3
Arms
15
Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF) patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal females undergoing IVF. Can it be used with the same efficacy in all patients?

Condition or Disease Intervention/Treatment Phase
  • Drug: Gonadotropins releasing hormone antagonist
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Can Antagonist Protocol be the Protocol of Choice in in Vitro Fertilization Patients?
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Aug 1, 2015
Anticipated Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Normal

Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC.

Drug: Gonadotropins releasing hormone antagonist
Other Names:
  • Cetrotide, Serono, Geneva, Switzerland

    		•
    Active Comparator: Poor responders

    Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC

    Drug: Gonadotropins releasing hormone antagonist
    Other Names:
  • Cetrotide, Serono, Geneva, Switzerland

    		•
    Active Comparator: Polycystic ovarian disease

    Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant(Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC

    Drug: Gonadotropins releasing hormone antagonist
    Other Names:
  • Cetrotide, Serono, Geneva, Switzerland

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of oocytes collected and fertilized [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 44 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • age: 20- 44 years

    • Poor responder females according to Bologna criteria

    • Polycystic ovarian disease females according to Rotterdam criteria

    • Females with infertility causes other than poor responders, or PCO; male factor or tubal block

    Exclusion Criteria:

    • refusal to get enrolled in the study

    • cases of infertility due to severe male factor

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr el aini hospital Cairo Egypt

    Sponsors and Collaborators

    • Woman's Health University Hospital, Egypt
    • Cairo University

    Investigators

    • Principal Investigator: Dina M Dakhly, MD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dina Mohamed Refaat Dakhly, lecturer of obstetrics and gynecology, Woman's Health University Hospital, Egypt
    ClinicalTrials.gov Identifier:
    NCT02335736
    Other Study ID Numbers:
    • AA2015
    First Posted:
    Jan 12, 2015
    Last Update Posted:
    Feb 15, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Dina Mohamed Refaat Dakhly, lecturer of obstetrics and gynecology, Woman's Health University Hospital, Egypt
    infertility
    Additional relevant MeSH terms:
    Infertility
    Cetrorelix
    Hormones
    Hormone Antagonists

    Study Results

    No Results Posted as of Feb 15, 2016