Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!
NCT ID: NCT06608186
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2024-10-01
2025-01-19
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Drospirenone
25 cases will receive drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
Drospirenone drug
A drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
cetrorelix
25 cases will receive cetrorelix from day 5 of stimualtion till hCG trigger day
Cetrorelix drug
a drug injection daily sc. from day 5 of stimulation till hCG trigger day
Interventions
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Cetrorelix drug
a drug injection daily sc. from day 5 of stimulation till hCG trigger day
Drospirenone drug
A drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* basal FSH level 12 mIU/mL
* previous ovarian surgery
* congenital uterine anomaly anomaly, intrauterine adhesion and male partner with non-obstructive azoospermia.
20 Years
38 Years
FEMALE
No
Sponsors
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Ahmed Saad
OTHER
Responsible Party
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Ahmed Saad
Professor of Obsterics & Gynecology
Principal Investigators
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Ahmed s saad, phD
Role: STUDY_DIRECTOR
Professor of OB & GYN
Locations
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Hawaa Fertility center
Banhā, Qalyubia Governorate, Egypt
Countries
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Other Identifiers
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Hawaa-10
Identifier Type: -
Identifier Source: org_study_id
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