The PROOF trial: PROtecting Ovaries and Fertility during chemotherapy
ISRCTN | ISRCTN96797814 |
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DOI | https://doi.org/10.1186/ISRCTN96797814 |
ClinicalTrials.gov number | NCT00380406 |
Secondary identifying numbers | MCT-82329 |
- Submission date
- 15/01/2008
- Registration date
- 15/01/2008
- Last edited
- 14/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sonya Kashyap
Scientific
Scientific
Clinical Epidemiology Program
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Ottawa Hospital
Civic Campus, Room C405
1053 Carling Ave.
Ottawa, Ontario
K1Y 4E9
Canada
Phone | +1 613 798 5555 ext. 19590 |
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sokashyap@ohri.ca |
Study information
Study design | Multicentre, two arm, placebo based randomised parallel trial, with study participant, study investigator, caregiver, outcome assessor, and data analyst blinded. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A randomised controlled trial of gonadotropin releasing hormone agonist (gnRHa) for fertility preservation in oncology patients |
Study acronym | PROOF |
Study objectives | Gonadotropin releasing hormone agonists will protect against ovarian failure and preserve measures of ovarian reserve in reproductive aged women undergoing gonadotoxic chemotherapy. |
Ethics approval(s) | Ethics approval received from the Research Ethics Board of the Ottawa Hospital (Canada) on the 10th May 2007 (for English-speaking patients) and 31st May 2007 (for French-speaking patients) (ref: 2006603-01H). |
Health condition(s) or problem(s) studied | Fertility preservation in female oncology patients |
Intervention | Intervention group: Lupron Depot (gonadotropin releasing hormone agonist - leuprolide acetate), trimonthly (every 3 months) intramuscular injections of 11.25 mg for 6 months with a maximum of 2 injections. Control group: Matching placebo without GnRHa, trimonthly (every 3 months) administration with a maximum of 2 injections. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Lupron Depot (gonadotropin releasing hormone agonist - leuprolide acetate) |
Primary outcome measure | Protection against ovarian failure measured at 12 months post cessation of chemotherapy. |
Secondary outcome measures | Sonographic (biophysical) and biochemical markers of ovarian reserve: 1. Sonographic: pelvic ultrasound for ovarian volume and antral follicle count 2. Biochemical markers: FSH, oestradiol (E2), progesterone, luteinising hormone (LH), Inhibin A & B The hormonal and ultrasound assessments will be done at 0, 3, 6, 9 and 12 months, in both study arms, post cessation. |
Overall study start date | 01/01/2007 |
Completion date | 31/12/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 30 |
Key inclusion criteria | Women who are: 1. Between ages 18 to 38 2. Who will be undergoing gonadotoxic (sterilising) 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). |
Key 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 less than 24 days between menses, age greater than 38, elevated serum follicular stimulating hormone (FSH) greater than 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 (less than 5) or elevated day 2 or 3 estradiol (greater than 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 |
Date of first enrolment | 01/01/2007 |
Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
Clinical Epidemiology Program
Ottawa, Ontario
K1Y 4E9
Canada
K1Y 4E9
Canada
Sponsor information
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Research organisation
Research organisation
c/o Carolyn Adams-Smith, Director
Finance & Grants Admin
725 Parkdale Avenue
Ottawa, Ontario
K1Y 4E9
Canada
Phone | +1 613 798 5555 ext.13148 |
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cadamssmith@ohri.ca | |
Website | http://www.ohri.ca/ |
https://ror.org/03c62dg59 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82329)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
14/02/2019: No publications found. Verifying results with principal investigator