The PROOF trial: PROtecting Ovaries and Fertility during chemotherapy

Not Applicable

Completed

• Conditions: Fertility preservation in female oncology patients; Pregnancy and Childbirth; Fertility preservation

• Registration Number: ISRCTN96797814
• Lead Sponsor: Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-15
• Study Completion: 2008-12-31
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 30

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).

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Protection against ovarian failure measured at 12 months post cessation of chemotherapy.

Secondary Outcome Measures

Name	Time	Method
<br> Sonographic (biophysical) and biochemical markers of ovarian reserve:<br> 1. Sonographic: pelvic ultrasound for ovarian volume and antral follicle count<br> 2. Biochemical markers: FSH, oestradiol (E2), progesterone, luteinising hormone (LH), Inhibin A & B<br><br> The hormonal and ultrasound assessments will be done at 0, 3, 6, 9 and 12 months, in both study arms, post cessation.<br>