Condition category
Pregnancy and Childbirth
Date applied
15/01/2008
Date assigned
15/01/2008
Last edited
19/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sonya Kashyap

ORCID ID

Contact details

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
+1 613 798 5555 ext. 19590
sokashyap@ohri.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00380406

Protocol/serial number

MCT-82329

Study information

Scientific title

A randomised controlled trial of gonadotropin releasing hormone agonist (gnRHa) for fertility preservation in oncology patients

Acronym

PROOF

Study hypothesis

Gonadotropin releasing hormone agonists will protect against ovarian failure and preserve measures of ovarian reserve in reproductive aged women undergoing gonadotoxic chemotherapy.

Ethics approval

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).

Study design

Multicentre, two arm, placebo based randomised parallel trial, with study participant, study investigator, caregiver, outcome assessor, and data analyst blinded.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Lupron Depot (gonadotropin releasing hormone agonist - leuprolide acetate)

Primary outcome measures

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 trial start date

01/01/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30

Participant 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

Recruitment start date

01/01/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Canada

Trial participating centre

Clinical Epidemiology Program
Ottawa, Ontario
K1Y 4E9
Canada

Sponsor information

Organisation

Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Sponsor details

c/o Carolyn Adams-Smith
Director
Finance & Grants Admin
725 Parkdale Avenue
Ottawa
Ontario
K1Y 4E9
Canada
+1 613 798 5555 ext.13148
cadamssmith@ohri.ca

Sponsor type

Research organisation

Website

http://www.ohri.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82329)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes