DRUG
Cetrorelix drug
a drug injection daily sc. from day 5 of stimulation till hCG trigger day
Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!
Status
Completed
Phase
Phase 1 / Phase 2
Enrollment
50
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Full 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.
Interventions
Treatment arms and agents.
DRUG
Drospirenone drug
A drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
Timeline
From registration to results.
First posted
Sep 23, 2024
Study start
Oct 1, 2024
Primary completion
Jan 19, 2025
Study completion
Jan 19, 2025
Results posted
Not reported
Registry updated
Jan 22, 2025
Outcomes
What the study measures.
Primary outcomes
number of cases to develop OHSS
Time frame · 1 week
cases that will develop OHSS
number of embryos
Time frame · 5 days
number of embryos developed
Secondary outcomes
clinical pregnancy rate
Time frame · 15 days after embryo transfer
serum pregnancy test after thawing of the embryos and embryo transfer
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 38 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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 locations
1 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Hawaa Fertility center
Banhā, Qalyubia Governorate, Egypt
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Cetrorelix.
NCT IDStudyPhase / statusEnrollmentUpdated
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A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
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Recruiting
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Phase 4
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Active, not recruiting
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