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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT00380406
Eligibility Criteria:
Inclusion Criteria:
* Women who are:
1. between ages 18 to 38;
2. who will be undergoing gonadotoxic (sterilizing) curative/ adjuvant chemotherapy for early stage disease; and
3. have provided informed consent. All subjects will be enrolled from the Ottawa Hospital Regional Cancer Institute (OHRCC) and the Cancer Center of South Eastern Ontario at Kingston General Hospital (CCSEO).
Exclusion Criteria:
* Women who:
1. have advanced stage disease and/or whose median survival is expected to be less than 6 months
2. have cancer of the ovaries, uterus, or fallopian tubes;
3. have clinical or biochemical evidence of diminished ovarian reserve (recent shortening of cycles \< 24 days between menses, age \> 38, elevated serum FSH (follicular stimulating hormone)\> 15 IU/L, or low antral follicle count (AFC- number of follicles less than 10 mm on day 2 or 3 of natural menses) on baseline pelvic ultrasound (\<5) or elevated day 2 or 3 estradiol (\> 280 pmol/ml);
4. have previously received chemotherapy or abdominal/pelvic radiation or have planned to receive abdomino/pelvic radiation;
5. are pregnant;
6. have contraindications to intramuscular injections; or
7. have a history of fractures secondary to/or documented osteoporosis.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
38 Years
Study:
NCT00380406
Study Brief:
Protocol Section:
NCT00380406