NCT06608186

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ahmed Saad · Academic / Other
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PCOS (Polycystic Ovary Syndrome)

Interventions

Type	Name	Description
DRUG	Cetrorelix drug	a drug injection daily sc. 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

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-01-19
• Completion: 2025-01-19
• First posted: 2024-09-23
• Last updated: 2025-01-22

Locations

1 site across 1 country: Egypt