DEPO-Trigger Trial: GnRH Agonist DEPOt TRIGGER for Final Oocyte Maturation

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

For breast cancer patients who are candidates to receive chemotherapy, concurrent use of temporary ovarian suppression with gonadotropin-releasing hormone agonists (GnRHa) can be offered as ovarian protection.

Because ovarian stimulation for oocyte cryopreservation is usually performed using a GnRH antagonist protocol and typically involves final oocyte maturation triggering with a GnRH agonist, the investigators designed this study to explore the feasibility of combining the final oocyte maturation trigger and the start of ovarian suppression. Short-term cotreatment with GnRH antagonists is needed to induce rapid luteolysis (in view of prevention of ovarian hyperstimulation).

To demonstrate the safety of GnRH agonist depot triggering followed by daily GnRH antagonist luteolysis, this pilot study is set out to analyse the endocrine profile and ovarian morphology of this novel protocol.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitair Ziekenhuis Brussel
• Collaborator: Universitaire Ziekenhuizen Leuven
• Treatments: Triptorelin Pamoate

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