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

• Sponsor: Zagazig University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05939284
• Collaborator: (none)
• Enrollment: 238
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.8
• Patients Per Site Per Month: 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PCOS	Drug: Injection of Cetrorelix; Drug: Oral insertion of dydrogeserone	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 238 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Progesterone-Primed Ovarian Stimulation Might be a Safe and Effective Alternative to GnRH-antagonist Protocol for Controlled-Ovarian Stimulation of Infertile PCOS Women
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Sep 14, 2022
• Actual Study Completion Date: Jan 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group C	Drug: Injection of Cetrorelix; Patients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day.
Active Comparator: Group S	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

Outcome Measures

Primary Outcome Measures

1. Success rate of PPOS in relation to Premature LH surge suppression [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zagazig university	Zagazig	Ash Sharqia Governorate	Egypt	44519

Sponsors and Collaborators

• Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Walid Mohamed Elnagar, Assistant professor of gynecology, Zagazig University
• ClinicalTrials.gov Identifier: NCT05939284
• Other Study ID Numbers: ZU-IRB #10874-25/6-2023
• First Posted: Jul 11, 2023
• Last Update Posted: Jul 11, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Cetrorelix

Study Results

No Results Posted as of Jul 11, 2023