Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?! (PPOS)

January 19, 2025 updated by: Ahmed Saad

Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS Cases

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this novel clinical trial is to study if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles in comparison to a gold standard drug cetrorelix:

All PCOS cases: 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.

At the day of hCG, lab testing will be done in addition to ultrasound assessment by transvaginal probe. the tests are: progesterone, E2, LH.

Assesment will be done for the number quality of follicles and the number quality of embryos developed, development of OHSS, vitrification/thawing of embryos after 1 month then the clinical and chemical pregnancy rate.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubiya
      • Banhā, Qalyubiya, Egypt, 13512
        • Hawaa Fertility center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PCOS was diagnosed according to the Rotterdam consensus criteria (two out of three of the following criteria):

    1. oligo- or anovulation
    2. clinical and/or biochemical signs of hyperandrogenism
    3. polycystic ovaries).
  • A diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumours, hyperprolactinemia and thyroid dysfunction were all rulled out.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drospirenone
25 cases will receive drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
Drug: Drospirenone drug
A drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
Active Comparator: cetrorelix
25 cases will receive cetrorelix from day 5 of stimualtion till hCG trigger day
Drug: Cetrorelix drug
a drug injection daily sc. from day 5 of stimulation till hCG trigger day
Other Names:
  • cetrorelix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of embryos
Time Frame: 5 days
number of embryos developed
5 days
number of cases to develop OHSS
Time Frame: 1 week
cases that will develop OHSS
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 15 days after embryo transfer
serum pregnancy test after thawing of the embryos and embryo transfer
15 days after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Saad

Investigators

  • Study Director: Ahmed s saad, phD, Professor of OB & GYN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

January 19, 2025

Study Completion (Actual)

January 19, 2025

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hawaa-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the protocol excel sheet

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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