Progesterone-Primed Ovarian Simulation in Controlled-ovarian Simulation of Infertile PCOS Patients

NCT ID: NCT05939284

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-01-25

Brief Summary

The study evaluated the safety and efficacy of the progesterone-primed ovarian stimulation (PPOS) coupled with gonadotropin (FSH) for infertile women with polycystic ovary syndrome (PCOS) who were assigned for ICSI and frozen blastocyst transfer.

200 infertile women were divided randomly into Group C, which received Cetrorelix injection (0.25 mg daily) on day-6, and Group S, which received oral dydrogesterone (20 mg/day) on day-2 of the menstrual cycle till the trigger day. All patients received an FSH injection of 225 IU daily from day-2 till triggering day. ICSI was performed and day-5 blastocysts underwent vitrification ultra-rapid cryopreservation till being transferred. Outcomes included the ability of PPOS to suppress the premature luteinizing hormone (LH) surge and prevent the development of ovarian hyperstimulation syndrome (OHSS), the incidence of profound LH suppression, the number of retrieved M2 oocyte and fertilization, chemical and clinical pregnancy rates, and the miscarriage rate.

Conditions

PCOS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group C

Group Type: ACTIVE_COMPARATOR

Injection of Cetrorelix

Intervention Type: DRUG

Patients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day.

Group S

Group Type: ACTIVE_COMPARATOR

Oral insertion of dydrogeserone

Intervention Type: DRUG

Patients received dydrogesterone in an oral dose of 20 mg/day in parallel with gonadotropin injection from day-2 of the menstrual cycle till the trigger day

Interventions

Injection of Cetrorelix

Patients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day.

Intervention Type: DRUG

Oral insertion of dydrogeserone

Patients received dydrogesterone in an oral dose of 20 mg/day in parallel with gonadotropin injection from day-2 of the menstrual cycle till the trigger day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Infertile PCOS women;
• aged 20-35 years;
• had BMI <35 kg/m2.

Exclusion Criteria

• Women who were younger than 20 or older than 35 years,
• obese of grade II or III,
• had poor OR, other causes of infertility,
• had previous attempts of IVF, had a history of repeated pregnancy loss.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Walid Mohamed Elnagar

Assistant professor of gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig university

Zagazig, Ash Sharqia Governorate, Egypt

Countries

Egypt

Other Identifiers

ZU-IRB #10874-25/6-2023

Identifier Type: -

Identifier Source: org_study_id