Clinical trial NCT06608186: Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!
Official title: Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: PCOS (Polycystic Ovary Syndrome)
Keywords: PCOS
PPOS
Drospirenone
Gn antagonist
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: number of cases to develop OHSS
timeFrame: 1 week
measure: number of embryos
timeFrame: 5 days
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 15 days after embryo transfer
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Hawaa Fertility center
state: Qalyubiya
Study officials:
affiliation: Professor of OB & GYN
name: Ahmed s saad, phD
role: STUDY_DIRECTOR
References: