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

Phase 1

Completed

• Conditions: PCOS (Polycystic Ovary Syndrome)
• Interventions: Drug: Drospirenone drug; Drug: Cetrorelix drug

• Registration Number: NCT06608186
• Lead Sponsor: Ahmed Saad

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

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 Timeline

• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-23
• Study Start: 2024-10-01
• Status Verified: 2025-01
• Primary Completion: 2025-01-19
• Study Completion: 2025-01-19
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drospirenone	Drospirenone drug	25 cases will receive drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
cetrorelix	Cetrorelix drug	25 cases will receive cetrorelix from day 5 of stimualtion till hCG trigger day

Primary Outcome Measures

Name	Time	Method
number of cases to develop OHSS	1 week	cases that will develop OHSS
number of embryos	5 days	number of embryos developed

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	15 days after embryo transfer	serum pregnancy test after thawing of the embryos and embryo transfer

Trial Locations

Locations (1)

Hawaa Fertility center; 🇪🇬 Banhā, Qalyubiya, Egypt