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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
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.
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.
The number of oocytes retrieved per patient
The number of oocyte retieved by ovum pick up after controlled ovarien stimulation
Time frame: 12 months
The number of MII oocytes/per patient
the grade of maturity of oocyte under microscope
Time frame: 12 months
The fertilization rate/per patient.
The number of fertilized oocyte by sperm
Time frame: 12 months
Number of frozen embryos/per patient
the number of embryo frozen
Time frame: 12 month
Incidence of early OHSS yes /no
size of th overies , presence of ascitis , pain and
Time frame: 12 months
Pregnancy outcomes
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.
Time frame: 12 months
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