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Clinical Trials/NCT05939284
NCT05939284
Completed
Not Applicable

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

Zagazig University1 site in 1 country238 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Injection of Cetrorelix
Conditions
PCOS
Sponsor
Zagazig University
Enrollment
238
Locations
1
Primary Endpoint
Success rate of PPOS in relation to Premature LH surge suppression
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
January 25, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Walid Mohamed Elnagar

Assistant professor of gynecology

Zagazig University

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.

Arms & Interventions

Group C

Intervention: Injection of Cetrorelix

Group S

Intervention: Oral insertion of dydrogeserone

Outcomes

Primary Outcomes

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.

Study Sites (1)

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