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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT03197532
Eligibility Criteria:
Inclusion Criteria for Group 1:
* Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment.
Inclusion Criteria for Group 2:
* Healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy.
Inclusion Criteria for Group 3:
* Healthy, late reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility.
Exclusion Criteria for all subjects:
* Pregnancy or lactation within the previous 3 months
* Use of hormonal contraception or replacement within the previous 3 months
* Body Mass Index greater than 30 kg/m2
* Excessive exercise greater than 1 hour per day
* Any medical condition other than cancer known to be associated with premature ovarian failure (such as Turners Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushings syndrome, hyperprolactinemia, and polycystic ovary syndrome)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT03197532
Study Brief:
Protocol Section:
NCT03197532