Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT04325295
Eligibility Criteria:
Inclusion Criteria:
anovulatory polycystic ovary syndrome resistant to first line ovulation induction.
* Polycystic ovary Syndrome defined by Rotterdam's criteria 2003
* Clomiphene resistance defined as failure to ovulate with a dose of 150mg per day for 5 days for 3 cycles
* Letrozole resistance defined as failure to ovulate with a dose of 7.5 mg per day for 5 days for 3 cycles
Exclusion Criteria:
* women's age \< 18 years or ≥ 40 years.
* BMI \> 40 kg/m2
* Patient with hyperprolactinaemia (serum prolactin above normal limits)
* Patients with hypogonadotropic hypogonadism (low serum FSH and LH)
* Patients with anovulation due to ovarian failure (serum FSH higher than normal limits)
* Male infertility
* Tubal abnormality, Known endometriosis, adenomyosis, uterine myomas or any other detected cause of female infertility
* History of ovarian surgery as laparoscopic ovarian drilling, ovarian cystectomy or oophorectomy
* History of pelvic radiation
* Patient recently treated with any type of induction of ovulation in the last three months.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04325295
Study Brief:
Protocol Section:
NCT04325295