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Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI

Sponsor
Zagazig University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05751681
Collaborator
(none)
79
Enrollment
1
Location
2
Arms
24.9
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles

Condition or Disease Intervention/Treatment Phase
  • Other: progestin primed ovarian stimulation protocol
  • Drug: dydrogesterone (Duphaston, Abbott)
  • Drug: Cetrotide
 N/A

Detailed Description

Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis. It acts on unidentified hypothalamic pulse oscillator neurons. In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion. This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary. The effect of progesterone appears to decrease GnRH pulse frequency which results in slowing down LH pulse frequency and reducing LH plasma concentrations

Study Design

Study Type:
Interventional
Anticipated Enrollment :
79 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection
Actual Study Start Date :
Feb 20, 2023
Anticipated Primary Completion Date :
Apr 20, 2024
Anticipated Study Completion Date :
Mar 20, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group (A)

will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle.

Other: progestin primed ovarian stimulation protocol
progestin primed ovarian stimulation protocol

Drug: dydrogesterone (Duphaston, Abbott)
20 mg oral dose of dydrogesterone (Duphaston, Abbott)
Active Comparator: group (B)

Gonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot.

Other: progestin primed ovarian stimulation protocol
progestin primed ovarian stimulation protocol

Drug: Cetrotide
0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist)
Other Names:
  • cetrorelix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy (Number of MII oocytes retrieved) [3 months]

      this outcome means to measure Percentage (number) of MII oocytes retrieved During our study

    2. Efficacy (Maturation index) [3 months]

      Maturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes

    Eligibility Criteria

    Criteria

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

    1. All patients should be candidates for ICSI.

    2. Age between 20-40 years.

    3. Body mass index 18-35 kg/m2.

    4. Diagnosis of PCOS according to modified Rotterdam's criteria

    Exclusion Criteria:
      1. Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zagazig University Zagazig Egypt 44511

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: mostafa fahmy, mcs, zagazig

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zagazig University
    ClinicalTrials.gov Identifier:
    NCT05751681
    Other Study ID Numbers:
    • 9736-20-9-2022
    First Posted:
    Mar 2, 2023
    Last Update Posted:
    Mar 2, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zagazig University
    IVF,ICSI,success rate
    Additional relevant MeSH terms:
    Infertility
    Cetrorelix
    Dydrogesterone
    Progestins

    Study Results

    No Results Posted as of Mar 2, 2023