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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03142035
Eligibility Criteria:
Inclusion Criteria:
* Primary or secondary infertility
* Endometriosis, stage III - IV, confirmed surgically by laparoscopy or laparotomy and/or radiologically by the presence of endometrioma on pelvic ultrasound or magnetic resonance imaging (MRI)
* Normal uterine cavity assessed by hysteroscopy or hysterosalpingogram
* Normal hormonal profile: TSH, prolactin, fasting blood sugar
* Normal semen analysis and mild/moderate male factor (Total motile sperm count \> 5 million/ml and/or normal WHO morphology \>20%)
* First IVF cycle or history of failed IVF cycles
* Washout period of ≥6 months after any diagnostic or therapeutic surgery for endometriosis or after any medical treatment with Dienogest or GnRH agonist.
Exclusion Criteria:
* • Low ovarian reserve defined by one of the following: low AMH ≤1.5ng/mL and/or basal day 3 FSH ≥ 10mIU/mL and/or basal day 3 Estradiol ≥ 60ng/mL and/or previous egg collection yield of ≤3 oocytes.
• Absolute contraindications to dienogest, including:
* undiagnosed abnormal vaginal bleeding
* pregnancy and/or lactation
* active venous thromboembolic disorder
* history of or current arterial and cardiovascular disease (eg, MI, CVA)
* diabetes mellitus with vascular involvement
* history of or current severe hepatic disease where liver function tests remain abnormal
* history of or current hepatic neoplasia (benign or malignant)
* known or suspected sex-hormone-dependent malignancy
* ocular lesions due to ophthalmic vascular disease, such as partial or complete vision loss or defect in visual fields
* current or history of migraine with focal aura
* hypersensitivity or poor tolerance to dienogest
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
38 Years
Study:
NCT03142035
Study Brief:
Protocol Section:
NCT03142035