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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT01702935
Eligibility Criteria:
* INCLUSION CRITERIA:
Subject is able to give consent/assent to participate in the protocol.
Listed below are acceptable medical conditions for inclusion in this protocol:
* Females older than 18 years with POI, POF, or DOR, undergoing ovarian biopsy by laparoscopy or clinically indicated abdominal surgery that provides access to the ovaries
* Clinical etiologies of POI may include, but are not limited to, idiopathic, autoimmune, chemotherapy related, or Turner s syndrome
* Subjects must have a diagnosis of premature ovarian failure or diminished ovarian reserve as defined by both:
1. Early follicular phase FSH \>15 IU/L
2. AMH \<0.16 ng/ml or below the level of detection for the assay used
* Females older than 18 years, with or without POI or POF, undergoing clinically indicated ovarian surgery
EXCLUSION CRITERIA:
Unable to comprehend the investigational nature of the protocol participation
Positive pregnancy test
Anticoagulation or known coagulopathy
Ovarian cancer
History of a previous laparoscopy or laparotomy revealing abdominal adhesions that would preclude ovarian biopsy
Previous bowel surgery.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01702935
Study Brief:
Protocol Section:
NCT01702935