Hawaa Fertility center
Banhā, Qalyubia Governorate, 13512, Egypt
NCT Number: NCT06608186
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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Notify Me20 year–38 year
Female
Interventional
Phase 1 / Phase 2
Banhā, Qalyubia Governorate, 13512, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a drug injection daily sc. from day 5 of stimulation till hCG trigger day
Other names: cetrorelix
A drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
Time frame: 1 week
cases that will develop OHSS
Time frame: 5 days
number of embryos developed
Time frame: 15 days after embryo transfer
serum pregnancy test after thawing of the embryos and embryo transfer
Ahmed Saad
Other
Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS Cases
Acronym: PPOS
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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