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

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Triptorelin.

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.

It had two arms (groups): GnRH agonist Depot form (experimental) and GnRH agonist Daily form (active comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

However, it should not be considered as an alternative to cryopreservation strategies in fertility preservation.

However, the protracted action of the GnRH agonist depot will result in prolonged stimulation of multiple corpora lutea, which will lead to enhanced production of steroids (estradiol and progesterone) and growth factors such as vascular endothelial growth factor.

Therefore, short-term cotreatment with GnRH antagonists is needed to induce rapid luteolysis.

Patients will be randomized before start of stimulation to either DEPOT group (group A) or control group (group B), only after patient eligibility has been established and patient consent has been obtained.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to women only aged from 18 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI ≥ 18 and ≤ 35 kg/m². Early stage breast cancer. Any hormone receptor status. Any HER status. Cryopreservation of oocytes and/or embryos.

The full record lists 8 inclusion and 2 exclusion criteria; among the exclusions: contra-indications for controlled ovarian stimulation or oocyte retrieval; necessity of neo-adjuvant chemotherapy.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Triptorelin study did not mask who received what.

It started in 2022-11-01 with completion listed for 2025-11-30.

It ran at 2 sites in Belgium (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Safety profile with regard to the risk of OHSS: assessment of change in ovarian volume (time frame: 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 (time frame: 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 (time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)).

It also tracked 3 secondary outcomes, for example Number of cumulus-oocyte complexes, Number of Metaphase II oocytes and Evaluation of climacteric symptoms.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Triptorelin in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.