UnknownPhase 1/2

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

Belgium30 participantsStarted 2022-11-01

Plain-language 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.

Who can participate

Age range18 Years – 35 Years

SexFEMALE

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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

What they're measuring

Safety profile with regard to the risk of OHSS: assessment of change in ovarian volume

Timeframe: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)

Safety profile with regard to the risk of OHSS: assessment of change in hematocrit

Timeframe: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)

Safety profile with regard to the risk of OHSS: assessment of change in hemoglobine

Timeframe: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)

Safety profile with regard to the risk of OHSS: assessment of change in White Blood cell Count

Timeframe: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)

Safety profile with regard to the risk of OHSS: assessment of change in Platelet Count

Timeframe: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)

Safety profile with regard to the risk of OHSS: assessment of change in estimated glomerular filtration rate (eGFR)

Timeframe: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)

Safety profile with regard to the risk of OHSS: assessment of change in Creatinine

Trial details

NCT IDNCT04616729

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

Contact for this trial

Michel De Vos, MD PhD

024776660 mdv@uzbrussel.be

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