GnRH Agonist for Oocyte Maturation in Breast Cancer Patients
DEPO-Trigger Trial: GnRH Agonist DEPOt TRIGGER for Final Oocyte Maturation in Breast Cancer Patients Undergoing Fertility Preservation: a Pilot Study
This study is testing whether a medication called triptorelin can help breast cancer patients undergoing chemotherapy safely mature their eggs while protecting their ovaries.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Boortmeerbeek, Brussels and 1 other locations) |
| Trial ID | NCT04616729 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a GnRH agonist, specifically triptorelin, to trigger final oocyte maturation in breast cancer patients undergoing chemotherapy. The study aims to combine this triggering with ovarian suppression to protect ovarian function during treatment. It will assess the safety and effectiveness of this novel approach by analyzing the endocrine profile and ovarian morphology of participants. The trial includes both Phase 1 and Phase 2 evaluations to ensure comprehensive safety and feasibility data.
Who should consider this trial
Good fit: Ideal candidates are women under 36 years old with early-stage breast cancer who are eligible for oocyte cryopreservation.
Not a fit: Patients who require neo-adjuvant chemotherapy or have contraindications for ovarian stimulation or oocyte retrieval may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance fertility preservation options for breast cancer patients undergoing chemotherapy.
How similar studies have performed: Previous studies have indicated beneficial effects of GnRH agonist ovarian suppression in reducing the risk of premature ovarian insufficiency and improving post-chemotherapy pregnancy rates, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \<36y * BMI ≥ 18 and ≤ 35 kg/m² * Early stage breast cancer * Any hormone receptor status * Any HER status * Cryopreservation of oocytes and/or embryos * Oncologist's approval to participate to the DEPO-trigger trial * Signed informed consent form Exclusion Criteria: * Contra-indications for controlled ovarian stimulation or oocyte retrieval * Necessity of neo-adjuvant chemotherapy
Where this trial is running
Boortmeerbeek, Brussels and 1 other locations
- Universitair Ziekenhuis Brussel — Boortmeerbeek, Brussels, Belgium (Recruiting)
- Universitaire Ziekenhuizen Leuven — Leuven, Vlaams-Brabant, Belgium (Not_yet_recruiting)
Study contacts
- Principal investigator: Michel De Vos, MD PhD — Universitair Ziekenhuis Brussel
- Study coordinator: Michel De Vos, MD PhD
- Email: mdv@uzbrussel.be
- Phone: 024776660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.