Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient

Fayoum University

Status: Not yet enrolling

Conditions: IVF; Infertility; Polycystic Ovary Syndrome

Treatments: Drug: Progesterone antagonist; Drug: conventional antagonist protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05847660

D 319

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Progesterone primed ovarian stimulation protocol.

Active Comparator group

Description:

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.

Treatment:

Drug: Progesterone antagonist

conventional antagonist protocol.

Active Comparator group

Description:

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.

Treatment:

Drug: conventional antagonist protocol