Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient

Not Applicable

Not yet recruiting

• Conditions: Infertility; Polycystic Ovary Syndrome; IVF
• Interventions: Drug: Progesterone antagonist; Drug: conventional antagonist protocol

• Registration Number: NCT05847660
• Lead Sponsor: Fayoum University

Brief Summary

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.

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 Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-04-27
• Last Update Submitted: 2023-04-27
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Study Start: 2023-06-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone primed ovarian stimulation protocol.	Progesterone antagonist	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.
conventional antagonist protocol.	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of early OHSS yes /no	12 months	size of th overies , presence of ascitis , pain and
Pregnancy outcomes	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.