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

Primary Purpose

PCOS

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Injection of Cetrorelix
Oral insertion of dydrogeserone
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Zagazig university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group C

Group S

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2023
Last Updated
July 3, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05939284
Brief Title
Progesterone-Primed Ovarian Simulation in Controlled-ovarian Simulation of Infertile PCOS Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 14, 2022 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Active Comparator
Arm Title
Group S
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Injection of Cetrorelix
Intervention Description
Patients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day.
Intervention Type
Drug
Intervention Name(s)
Oral insertion of dydrogeserone
Intervention Description
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 Outcome Measure Information:
Title
Success rate of PPOS in relation to Premature LH surge suppression
Description
the success rate of PPOS as regards the suppression of premature LH surge and prevention of the development of OHSS.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Zagazig university
City
Zagazig
State/Province
Ash Sharqia Governorate
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

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

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