The PROOF trial: PROtecting Ovaries and Fertility during chemotherapy

ISRCTN ISRCTN96797814
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

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
Email sokashyap@ohri.ca

Study information

Study designMulticentre, two arm, placebo based randomised parallel trial, with study participant, study investigator, caregiver, outcome assessor, and data analyst blinded.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised controlled trial of gonadotropin releasing hormone agonist (gnRHa) for fertility preservation in oncology patients
Study acronymPROOF
Study objectivesGonadotropin 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) studiedFertility preservation in female oncology patients
InterventionIntervention 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Lupron Depot (gonadotropin releasing hormone agonist - leuprolide acetate)
Primary outcome measureProtection against ovarian failure measured at 12 months post cessation of chemotherapy.
Secondary outcome measuresSonographic (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 date01/01/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants30
Key inclusion criteriaWomen 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 criteriaWomen 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 enrolment01/01/2007
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

Clinical Epidemiology Program
Ottawa, Ontario
K1Y 4E9
Canada

Sponsor information

Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
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
Email cadamssmith@ohri.ca
Website http://www.ohri.ca/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

14/02/2019: No publications found. Verifying results with principal investigator