Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient

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.

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.

this is a randomized controlled non-blinded study. it will include 210 pt all of them PCO pt with infertility

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.

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.

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.

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.

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.