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Protocols of IVF/ICSI in Poor Responders

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04356105
Collaborator
(none)
132
Enrollment
2
Locations
2
Arms
17
Actual Duration (Months)
66
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles

Condition or Disease Intervention/Treatment Phase
  • Drug: Minimal stimulation protocol
  • Drug: Microflare protocol
  • Procedure: IVF/ICSI cycle
 Phase 3

Detailed Description

The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.

Study Design

Study Type:
Interventional
Actual Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the studyTwo groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Minimal Stimulation in a Combined Letrozole Antagonist Protocol Versus Microflare Protocol in Poor Responders Undergoing Invitrofertilization/ Intracytoplasmic Sperm Injection; Randomized Parallel Study
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Minimal Stimulation Group

Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist

Drug: Minimal stimulation protocol
Letrozole, Recombinant FSH, GnRH antagonist
Other Names:
  • Ovarian induction protocol

    • Procedure: IVF/ICSI cycle
    Involving ovum pickup and embryo transfer
    Active Comparator: Microflare Group

    Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH

    Drug: Microflare protocol
    OCP, GnRH agonist, Recombinant FSH
    Other Names:
  • Ovarian induction protocol

    • Procedure: IVF/ICSI cycle
    Involving ovum pickup and embryo transfer

    Outcome Measures

    Primary Outcome Measures

    1. Number of oocytes retrieved [10 to 14 days]

      the number of oocytes collected from each participants in the two groups on the day of ovum pickup

    Secondary Outcome Measures

    1. Number of MII oocytes retrieved [10 to 14 days]

      The mature oocytes colloected on the day of ovum pickup

    2. Number of fertilized oocytes [2 days]

      Number of oocytes fertilized

    3. Number of embryos transferred [Day 3 after ovum pickup]

      Number of embryos transferred in the induction cycle

    4. Number of embryos cryopreserved [Day 3 after ovum pickup]

      Any surplus good quality embryos available for cryopreservation

    5. Chemical pregnancy rate [14 days after embryo ransfer]

      Positive pregnancy test

    6. Clinical pregnancy rate [5 to 7 weeks after embryo transfer]

      Positive heart beat

    7. Early miscarriage rate [12 weeks]

      loss of pregnancy before 12 weeks

    8. Ongoing pregnancy rate [12 weeks]

      pregnancy beyond 12 weeks

    9. Live birth rate [28 to 40 weeks]

      Delivery beyond 28 weeks

    Other Outcome Measures

    1. Cancellation rate [10 to 14 days]

      Number of cycles not reaching ovum pickup

    2. Total dose of recombinant FSH [10 to 14 days]

      The mean total dose of recombinant FSH used in the cycle of treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 43 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:

    1. Advanced maternal age

    2. Previous poor ovarian response

    3. Abnormal tests of ovarian reserve (AFC < 5-7, AMH <0.5-1.1 ng/ml)

    Exclusion Criteria:

    1. Age > 43 years

    2. baseline FSH >15 mIU/ml

    3. Previous ovarian surgery

    4. Ovarian endometrioma

    5. Uterine anomaly or myoma

    6. Any medical disorder

    7. Any hormonal disorder eg. hyperprolactinemia

    8. BMI > 30 kg/m2

    9. Severe male factor

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini) Cairo Egypt 12311
    2 Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Sarwat Ahwany, MD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yasmin Ahmed Bassiouny, Assisstant Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04356105
    Other Study ID Numbers:
    • 12020
    First Posted:
    Apr 22, 2020
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Nov 16, 2021