A Randomized Controlled Study of Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patients in Intracytoplasmic Sperm Injection Cycles
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fayoum University
- Enrollment
- 210
- Primary Endpoint
- The fertilization rate/per patient.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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).
- •Age less than 40 years old.
- •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.
Arms & Interventions
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.
Intervention: Progesterone antagonist (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.
Intervention: conventional antagonist protocol (Drug)
Outcomes
Primary Outcomes
The fertilization rate/per patient.
Time Frame: 12 months
The number of fertilized oocyte by sperm
Number of frozen embryos/per patient
Time Frame: 12 month
the number of embryo frozen
The number of oocytes retrieved per patient
Time Frame: 12 months
The number of oocyte retieved by ovum pick up after controlled ovarien stimulation
The number of MII oocytes/per patient
Time Frame: 12 months
the grade of maturity of oocyte under microscope
Secondary Outcomes
- Incidence of early OHSS yes /no(12 months)
- Pregnancy outcomes(12 months)
Investigators
rehab abdelhamid aboshama
associate professor of obstetrics and gynecology
Fayoum University