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 range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

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

View on ClinicalTrials.gov More Breast Cancer Female trials