Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608186
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS Cases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPOS
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
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 tabletd or cetrorelix injectiond 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 vitrificationthawing of embryos after 1 month then the clinical and chemical pregnancy rate
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 tabletd or cetrorelix injectiond 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 vitrificationthawing of embryos after 1 month then the clinical and chemical pregnancy rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None