Clinical trial · Interventional
PROtecting Ovaries and Fertility During Chemotherapy - The PROOF Trial
PROtecting Ovaries and Fertility During Chemotherapy - The PROOF Trial: A Randomized Controlled Trial of Gonadotropin Releasing Hormone Agonist (GnRHa) for Fertility Preservation in Oncology Patients
NCT00380406CI-TRIAL-00026803PROOFcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Fertility Preservation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprolide acetate | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Leuprolide acetate
- type
- ACTIVE_COMPARATOR
- label
- depot GnRHa (Leuprolide acetate (LA) 11.25 mg intramuscularly)
- interventionNames
- Drug: Leuprolide acetate
Primary outcomes (1)
- measure
- Protection against ovarian failure
- timeFrame
- 12 months post Chemo therapy
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
Inclusion Criteria: * Women who are: 1. between ages 18 to 38; 2. who will be undergoing gonadotoxic (sterilizing) 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 \< 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); 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.
References
Publications (0)
Data not yet available
No reference posted for this study.