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

Zagazig University

Status: Completed

Conditions: PCOS

Treatments: Drug: Injection of Cetrorelix; Drug: Oral insertion of dydrogeserone

Study type: Interventional

Funder types: Other

Identifiers

NCT05939284

ZU-IRB #10874-25/6-2023

Details and patient eligibility

About

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.

Enrollment: 238 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

Group C

Active Comparator group

Treatment:

Drug: Injection of Cetrorelix

Group S

Active Comparator group

Treatment:

Drug: Oral insertion of dydrogeserone