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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT03206892
Eligibility Criteria:
Inclusion Criteria:
* PCOS according to Rotterdam Criteria (2 out of 3):
* polycystic ovaries (12 or more follicles in each ovary and/or increased ovarian volume \>10 cm3).
* oligo- or an-ovulation.
* clinical and/or biochemical hyperandrogenisim. After exclusion of other aetiologies for irregular cycles.
* Indications of laparoscopic ovarian drilling:
* clomiphene citrate- resistance or failure: failure to conceive after 6 to 9 cycles.
* other indications for laparoscopy.
* before gonadotropin administration to decrease risk of OHSS and multiple pregnancy.
* before ART to decrease risk of severe OHSS in women who previously had canceled IVF cycles due to OHSS risk or who suffered from OHSS in a previous treatment.
Exclusion Criteria:
* previous 2 or more laparotomies.
* chronic pelvic pain, endometriosis or pelvic inflammatory diseases to avoid pelvic adhesions and bias in the quantification of postoperative pain.
* High BMI (\>35kg/m2)
* do not possess a native umbilicus.
* advanced gynaecological surgeries or malignant disorders (TLH, ALVH, laparoscopic myomectomy).
* contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or Trendelnburg position.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT03206892
Study Brief:
Protocol Section:
NCT03206892