PCOS (Polycystic Ovary Syndrome)
Conditions
Keywords
PCOS, PPOS, Drospirenone, Gn antagonist
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
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
DRUGCetrorelix drug
a drug injection daily sc. from day 5 of stimulation till hCG trigger day
A drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
Sponsors
Ahmed Saad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
statistician
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 38 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of cases to develop OHSS | 1 week | cases that will develop OHSS |
| number of embryos | 5 days | number of embryos developed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate | 15 days after embryo transfer | serum pregnancy test after thawing of the embryos and embryo transfer |
Countries
Egypt
Outcome results
None listed