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Effect of Controlled Ovarian Stimulation in Quality of Oocyte and Embryo

Sponsor
Minia University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04539067
Collaborator
(none)
70
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Investigate and compare the efficacy of H FSH plus HMG Vs HMG alone on oocyte and embryo quality in IcsI patients

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

70 patients divided in to 2groups Group A controlled ovarian stimulation with H FSH and HHMg Group B controlled ovarian stimulation with HMG alone Results will be discussed later

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Controlled Ovarian Stimulation With H FSH and HHMg Vs HMG Alone on Oocyte and Embryo Quality in IcsI Patients
Anticipated Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: HMG group

Induction of ovulation from 2nd day of cycle Follow diameter of follicle When follicle 18:22mm Receive HMG

Drug: HHMG
Induction of ovulation from the 2nd day of cycle to 5th day then follow the diameter of follicle Use transvaginal ultrasound When diameter of follicle 18 to 22 patients receiving HMG
Other Names:
  • Using HHMG for induction

    		•
    Experimental: H FSH plus HHMG

    Follow up ovulation from the 2nd day to 5th of menstruation cycle When follicle diameter 18mm to 22mm made induction of ovulation

    Drug: HHMG
    Induction of ovulation from the 2nd day of cycle to 5th day then follow the diameter of follicle Use transvaginal ultrasound When diameter of follicle 18 to 22 patients receiving HMG
    Other Names:
  • Using HHMG for induction

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison between the efficacy of controlled ovarian stimulation with H FSH plus HMG Vs HmG alone on oocyte and embryo quality in IcsI patients [9 months]

      Comparison between the efficacy of controlled ovarian stimulation with H FSH plus HMG Vs HmG alone on oocyte and embryo quality in IcsI patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Infertil women aged from 20_35yr

    2. Normal utreus

    3. Normal ovaries

    4. unexplained infertility

    5. no endometriosis

    Exclusion Criteria:

    1 - poor responders to gonadotropin 2-Prior history of more than 3unsucceful ICSI 3-Any malformation of sexual organs

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Minia University

    Investigators

    • Principal Investigator: Marwa Ba Tarahony, Faculty of Medicine, Minia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marwa Bahgat Tarahony, Eygpt Minia, Minia University
    ClinicalTrials.gov Identifier:
    NCT04539067
    Other Study ID Numbers:
    • 635_5/2020
    First Posted:
    Sep 4, 2020
    Last Update Posted:
    Sep 4, 2020
    Last Verified:
    Aug 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 4, 2020