Status:
COMPLETED
PROtecting Ovaries and Fertility During Chemotherapy - The PROOF Trial
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
University of Ottawa
Queen's University
Conditions:
Fertility Preservation
Cancer
Eligibility:
FEMALE
18-38 years
Phase:
PHASE3
Brief 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 chemo...
Detailed Description
Fertility preservation is defined as the maintenance of one's ability to reproduce. The hypothesis for this study is that medical treatment (GnRHa) will help female cancer patients, receiving sterili...
Eligibility Criteria
Inclusion
- Women who are:
- between ages 18 to 38;
- who will be undergoing gonadotoxic (sterilizing) curative/ adjuvant chemotherapy for early stage disease; and
- 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
- Women who:
- have advanced stage disease and/or whose median survival is expected to be less than 6 months
- have cancer of the ovaries, uterus, or fallopian tubes;
- 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);
- have previously received chemotherapy or abdominal/pelvic radiation or have planned to receive abdomino/pelvic radiation;
- are pregnant;
- have contraindications to intramuscular injections; or
- have a history of fractures secondary to/or documented osteoporosis.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00380406
Start Date
January 1 2007
End Date
April 1 2010
Last Update
April 5 2017
Active Locations (4)
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1
Cancer Centre of Southeastern Ontario
Kingston, Ontario, Canada, K7L 5P9
2
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
3
Kingston General Hospital
Ottawa, Ontario, Canada
4
Ottawa Hospital/OHRI
Ottawa, Ontario, Canada