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

March 1, 2023 updated by: Zagazig University

Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Zagazig, Egypt, 44511
        • Recruiting
        • Zagazig University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy (Number of MII oocytes retrieved)
Time Frame: 3 months
this outcome means to measure Percentage (number) of MII oocytes retrieved During our study
3 months
Efficacy (Maturation index)
Time Frame: 3 months
Maturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: mostafa fahmy, mcs, Zagazig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Anticipated)

April 20, 2024

Study Completion (Anticipated)

March 20, 2025

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9736-20-9-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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