PROtecting Ovaries and Fertility During Chemotherapy - The PROOF Trial

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether gonadotropin releasing hormone agonists (medical therapy) will protect against ovarian failure in reproductive aged women undergoing sterilizing chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Queen's University; University of Ottawa
• Treatments: Leuprolide

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.