Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient

April 27, 2023 updated by: rehab abdelhamid aboshama, Fayoum University

A Randomized Controlled Study of Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patients in Intracytoplasmic Sperm Injection Cycles

this study is designed to compare the Progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate PCO patients in ICSI cycles to decrease cost and decrease OHSS.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A Randomized controlled, non-blinded study (parallel-group study with 1:1 randomization) will be conducted at a Specialized Authorized IVF unit starting from January 2023 till completing the sample size. Randomization will be generated by a computer and held with one of the experimenters, and (n) of the black and red cards will be used for allocation concealment.

Participants: All PCO patients will be given informed consent about the study aims and written consent will be taken at the first visit to the infertility clinic of the Specialized Authorized IVF unit.

Patients will be categorized as (Group A) Progesterone primed ovarian stimulation protocol. (Group B) conventional antagonist protocol.

Study Type

Interventional

Enrollment (Anticipated)

210

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

  • Name: rehab A aboshama, Ass Professor
  • Phone Number: +2 01156608221
  • Email: ras07@fayoum.edu.eg

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- 1. PCO patients based on Rotterdam criteria (2003), including polycystic ovaries, oligo-anovulation, as well as the biochemical or clinical signs of hyperandrogenism (Rotterdam et al, 2003).

2. Age less than 40 years old. 3. Primary infertility for 2 years and secondary infertility for 1 year.

Exclusion Criteria:

- Non-PCO patients as:

  • Congenital adrenal hyperplasia
  • Hyperprolactinemia.
  • Recurrent implantation failure.
  • Hydrosalpinx.
  • Uterine pathology.
  • Uncontrolled medical disorder eg DM, HTN
  • Male factor infertility.

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
Active Comparator: Progesterone primed ovarian stimulation protocol.
Group (A): Women in progesterone primed (PPOS) will be prescribed a 30 mg oral dose of dydrogesterone (Duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until the triggering day. Vaginal sonography will be done for all patients since 6th day of the cycle.
Drug: Progesterone antagonist
Group (A): Women in progesterone primed (PPOS) will prescribed 30 mg oral dose of dydrogesterone (duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until triggering day. Vaginal sonography will be done for all patients since the 6th day of the cycle.
Other Names:
  • duphaston
Active Comparator: conventional antagonist protocol.
Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of Cetrotide (Merck-Serono, Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day.
Drug: conventional antagonist protocol
Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of cetrotide (Merck-Serono ,Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day.
Other Names:
  • 0.25 mg of cetrotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of oocytes retrieved per patient
Time Frame: 12 months
The number of oocyte retieved by ovum pick up after controlled ovarien stimulation
12 months
The number of MII oocytes/per patient
Time Frame: 12 months
the grade of maturity of oocyte under microscope
12 months
The fertilization rate/per patient.
Time Frame: 12 months
The number of fertilized oocyte by sperm
12 months
Number of frozen embryos/per patient
Time Frame: 12 month
the number of embryo frozen
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of early OHSS yes /no
Time Frame: 12 months
size of th overies , presence of ascitis , pain and
12 months
Pregnancy outcomes
Time Frame: 12 months
  1. Chemical pregnancy will be determined by serum β hCG > 50 IU/L two weeks after ET.
  2. In addition, clinical pregnancy will be confirmed by detecting fetal heartbeats 2 weeks following the positive β hCG.
12 months

Collaborators and Investigators

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

Sponsor

Fayoum University

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 (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Estimate)

May 8, 2023

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D 319

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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