NCT06608186

Brief Summary

The goal of this clinical trial is to learn if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles. The main questions it aims to answer are: Can drospirenone prevent LH surge in controlled ovarian stimulation in PCOS cases ? Can it prevent the occurance of ovarian hyperstimulation? Researchers will compare drospirenone to cetrorelix (A well known drug for such cases) to see if drospirenone works the same way. Participants will: Take drospirenone or cetrorelix from stimulation day 5 ( 5 days of ovarian stimulation) till day of hCG trigger \- monitoring will be done before the cycle and through the cycles with vaginal ultrasound assessment and lab testing

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

September 19, 2024

Last Update Submit

January 19, 2025

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

PCOSPPOSDrospirenoneGn antagonist

Outcome Measures

Primary Outcomes (2)

  • number of cases to develop OHSS

    cases that will develop OHSS

    1 week

  • number of embryos

    number of embryos developed

    5 days

Secondary Outcomes (1)

  • clinical pregnancy rate

    15 days after embryo transfer

Study Arms (2)

Drospirenone

EXPERIMENTAL

25 cases will receive drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day

Drug: Drospirenone drug

cetrorelix

ACTIVE COMPARATOR

25 cases will receive cetrorelix from day 5 of stimualtion till hCG trigger day

Drug: Cetrorelix drug

Interventions

Cetrorelix drugDRUG

a drug injection daily sc. from day 5 of stimulation till hCG trigger day

Also known as: cetrorelix
cetrorelix
Drospirenone drugDRUG

A drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day

Drospirenone

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale gender phenotypically and genetically
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS was diagnosed according to the Rotterdam consensus criteria (two out of three of the following criteria):
  • oligo- or anovulation
  • clinical and/or biochemical signs of hyperandrogenism
  • polycystic ovaries).
  • A diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumours, hyperprolactinemia and thyroid dysfunction were all rulled out.

You may not qualify if:

  • age 38 years
  • basal FSH level 12 mIU/mL
  • previous ovarian surgery
  • congenital uterine anomaly anomaly, intrauterine adhesion and male partner with non-obstructive azoospermia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawaa Fertility center

Banhā, Qalyubia Governorate, 13512, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

cetrorelixdrospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ahmed s saad, phD

    Professor of OB & GYN

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 50 case in this novel trial. 25 in each group will be randomized after taking 5 days of ovarian stimulation to either drospirenone tablet/d or cetrorelix injection/d till the day of hCG.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Obsterics & Gynecology

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 23, 2024

Study Start

October 1, 2024

Primary Completion

January 19, 2025

Study Completion

January 19, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

the protocol excel sheet

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
6 months
Access Criteria
6 months

Locations

EG(1)