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

PCOS Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05939284
• Other study ID #: ZU-IRB #10874-25/6-2023
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: July 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: January 25, 2023
• Est. primary completion date: September 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• PCOS

Intervention

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

Locations

Country	Name	City	State
Egypt	Zagazig university	Zagazig	Ash Sharqia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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