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The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03209687
Collaborator
(none)
600
Enrollment
1
Location
2
Arms
61.3
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to test the hypothesis that addition of daily small dose of human menopausal gonadotropin (HMG) drug following oocytes retrieval could improve the fertility outcome in women undergoing in-vitro fertilization

Condition or Disease Intervention/Treatment Phase
  • Drug: human menopausal gonadotropin
 Phase 4

Detailed Description

The study will be conducted in the IVF unit of Cairo University. Females undergoing ICSI cycles in the age between 20 and 40 years will be allocated to one of 2 groups. Long agonist protocol will be used. Allocation to either one of 2 groups will be done on the day of oocytes retrieval. The first group will take (in addition to the routine care) daily human menopausal gonadotropin drug injection for 2 weeks. The second group will receive the routine care.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)
Actual Study Start Date :
Jul 6, 2017
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Human menopausal gonadotropin (HMG)

This group will take daily subcutaneous 75 IU (international unit) of human menopausal gonadotropin (HMG) in addition to the usual luteal phase support from the day of ovum pickup and will be continued for 2 weeks

Drug: human menopausal gonadotropin
Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles
Other Names:
  • Merional

    		•
    No Intervention: Routine care

    This group will receive the routine care for luteal phase support

    Outcome Measures

    Primary Outcome Measures

    1. Live birth rate [This outcome will be calculated 2 years after enrollment of the first patient in the study]

      The live birth rate will be calculated by a statistician for each group

    Secondary Outcome Measures

    1. Clinical pregnancy rate [This outcome will be calculated 2 years after enrollment of the first patient in the study]

      The clinical pregnancy rate will be calculated by a statistician for each group

    2. Implantation rate [This outcome will be calculated 2 years after enrollment of the first patient in the study]

      The implantation rate will be calculated by a statistician for each group

    3. Miscarriage rate [This outcome will be calculated 2 years after enrollment of the first patient in the study]

      The miscarriage rate will be calculated by a statistician for each group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Females undergoing Intra-Cytoplasmic Sperm Injection (ICSI) cycles

    • Age between 20 and 40 years

    Exclusion Criteria:
    • Females who have high response (estradiol at time of ovulation trigger is > 5000 pg/ml or more than 15 oocytes are retrieved)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital Cairo Greater Cairo Egypt 11956

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Abdelmaguid Ramzy, M.D., Cairo University
    • Study Director: Eman Omran, M.D., Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdel-Maguid Ramzy, Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03209687
    Other Study ID Numbers:
    • 3778
    First Posted:
    Jul 6, 2017
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Infertility
    Menotropins

    Study Results

    No Results Posted as of Mar 8, 2022