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Trial Title:
Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!
NCT ID:
NCT06608186
Condition:
PCOS (Polycystic Ovary Syndrome)
Conditions: Official terms:
Polycystic Ovary Syndrome
Drospirenone
Cetrorelix
Conditions: Keywords:
PCOS
PPOS
Drospirenone
Gn antagonist
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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.
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
statistician
Intervention:
Intervention type:
Drug
Intervention name:
Cetrorelix drug
Description:
a drug injection daily sc. from day 5 of stimulation till hCG trigger day
Arm group label:
cetrorelix
Other name:
cetrorelix
Intervention type:
Drug
Intervention name:
Drospirenone drug
Description:
A drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG
trigger day
Arm group label:
Drospirenone
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
female gender phenotypically and genetically
Minimum age:
20 Years
Maximum age:
38 Years
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
January 10, 2025
Lead sponsor:
Agency:
Ahmed Saad
Agency class:
Other
Source:
Benha University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06608186
