Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovary Syndrome, Infertility, IVF

Intervention / Treatment
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* Drug: Progesterone antagonist
* Drug: conventional antagonist protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: this is a randomized controlled non-blinded study. it will include 210 pt all of them PCO pt with infertility
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone primed ovarian stimulation protocol.<br>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<br>* 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.<br>* Other names: duphaston;|
| Active Comparator: conventional antagonist protocol.<br>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<br>* 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.<br>* Other names: 0.25 mg of cetrotide;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICSI, progesterone, antagonist protocol, Polycystic ovary disease