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OpenTrials
Completed

NCT Number: NCT06608186

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

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

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Key information

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hawaa Fertility center

Banhā, Qalyubia Governorate, 13512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Cetrorelix drug

Drug

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

Other names: cetrorelix

Drospirenone drug

Drug

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

Primary outcomes

  1. number of cases to develop OHSS

    Time frame: 1 week

    cases that will develop OHSS

  2. number of embryos

    Time frame: 5 days

    number of embryos developed

Secondary outcomes

  1. clinical pregnancy rate

    Time frame: 15 days after embryo transfer

    serum pregnancy test after thawing of the embryos and embryo transfer

Sponsors and collaborators

Lead sponsor

Ahmed Saad

Other

Registry information

Official study title

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

Acronym: PPOS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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