NCT05847660

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Fayoum University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Polycystic Ovary Syndrome
• Infertility
• IVF

Interventions

Type	Name	Description
DRUG	Progesterone antagonist	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.
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-01
• Completion: 2024-07-01
• First posted: 2023-05-06
• Last updated: 2023-05-06