- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05939284
Progesterone-Primed Ovarian Simulation in Controlled-ovarian Simulation of Infertile PCOS Patients
Progesterone-Primed Ovarian Stimulation Might be a Safe and Effective Alternative to GnRH-antagonist Protocol for Controlled-Ovarian Stimulation of Infertile PCOS Women
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ash Sharqia Governorate
-
Zagazig, Ash Sharqia Governorate, Egypt, 44519
- Zagazig University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group C
|
Patients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day.
|
Active Comparator: Group S
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZU-IRB #10874-25/6-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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