Skip to main content
OpenTrials
Completed

NCT Number: NCT05939284

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PCOS

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university

Zagazig, Ash Sharqia Governorate, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Injection of Cetrorelix

Drug

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

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

Primary outcomes

  1. Success rate of PPOS in relation to Premature LH surge suppression

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Progesterone-Primed Ovarian Stimulation Might be a Safe and Effective Alternative to GnRH-antagonist Protocol for Controlled-Ovarian Stimulation of Infertile PCOS Women

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 11, 2023
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.