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

NCT05939284 | Completed

• 1 other identifier: ZU-IRB #10874-25/6-2023
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Success rate of PPOS in relation to Premature LH surge suppression

  the success rate of PPOS as regards the suppression of premature LH surge and prevention of the development of OHSS.

  12 months

Study Arms (2)

Group C

ACTIVE COMPARATOR

Drug: Injection of Cetrorelix

Group S

ACTIVE COMPARATOR

Drug: Oral insertion of dydrogeserone

Interventions

Injection of Cetrorelix DRUG

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

Group C

Oral insertion of dydrogeserone 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

Group S

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Ash Sharqia Governorate, 44519, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of gynecology

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: June 1, 2021
• Primary Completion: September 14, 2022
• Study Completion: January 25, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

EG (1)