Depo-Trigger trial: Gonadotropin-releasing Hormone agonist in Depot-form for combination of final oocyte maturation and ovarian protection in breast cancer patients undergoing fertility preservation: a pilot study.

Depo-Trigger trial: GnRH agonist DEPOt TRIGGER for final oocyte maturation in breast cancer patients undergoing fertility preservation: a pilot study. - DEPO-TRIGGER

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005208-20-BE

Enrollment

Registered

2021-06-08

Start date

2022-08-10

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female patients with breast cancer MedDRA version: 20.0 Level: PT Classification code 10006279 Term: Breast neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Triptoreline Acetate Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: TRIPTORELIN ACETATE CAS Number: 140194-24-7 Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: · Contra-indications for controlled ovarian stimulation or oocyte retrieval · Patients with a baseline LH level <2 IU/L

Design outcomes

Primary

Measure	Time frame
Main Objective: For breast cancer patients who are candidates to receive chemotherapy, concurrent use of temporary ovarian suppression with gonadotropinreleasing hormone agonists (GnRHa) can be offered as ovarian protection. Because ovarian stimulation for oocyte cryopreservation (in view of fertility preservation) is usually performed using a GnRH antagonist protocol and typically involves final oocyte maturation triggering with a GnRH agonist, we designed this study to explore the feasibility of combining the final oocyte maturation trigger and the start of ovarian suppression. One group of patients will receive the low dose GnRH agonist in view of maturation trigger followed by the depot form one week later. The other group will be triggered by the depot form. To demonstrate the safety of GnRH agonist depot triggering followed by daily GnRH antagonist luteolysis, we set out to perform a pilot study to analyse the endocrine profile and ovarian mor-phology of this novel protocol.;Secondary Objective: Furthermore the effect of the Depot Trigger on the number of cumulus oocyte complexes and number of mature oocytes will be evaluated. Secondary objectives will be to compare number of cumulus-oocyte complexes and number of mature oocytes.;Primary end point(s): · Hormone levels (E2, P4, LH and FSH) after ovulation trigger. · Ovarian volume at fixed time points following ovulation trigger (day 3- 5-7) and ovarian volume reduction.;Timepoint(s) of evaluation of this end point: Fixed blood samples and ultrasound evaluations on day 3, 5, 7 and 14 after transvaginal oocyte retrieval	—

Measure

Time frame

Main Objective: For breast cancer patients who are candidates to receive chemotherapy, concurrent use of temporary ovarian suppression with gonadotropinreleasing hormone agonists (GnRHa) can be offered as ovarian protection. Because ovarian stimulation for oocyte cryopreservation (in view of fertility preservation) is usually performed using a GnRH antagonist protocol and typically involves final oocyte maturation triggering with a GnRH agonist, we designed this study to explore the feasibility of combining the final oocyte maturation trigger and the start of ovarian suppression. One group of patients will receive the low dose GnRH agonist in view of maturation trigger followed by the depot form one week later. The other group will be triggered by the depot form. To demonstrate the safety of GnRH agonist depot triggering followed by daily GnRH antagonist luteolysis, we set out to perform a pilot study to analyse the endocrine profile and ovarian mor-phology of this novel protocol.;Secondary Objective: Furthermore the effect of the Depot Trigger on the number of cumulus oocyte complexes and number of mature oocytes will be evaluated. Secondary objectives will be to compare number of cumulus-oocyte complexes and number of mature oocytes.;Primary end point(s): · Hormone levels (E2, P4, LH and FSH) after ovulation trigger. · Ovarian volume at fixed time points following ovulation trigger (day 3- 5-7) and ovarian volume reduction.;Timepoint(s) of evaluation of this end point: Fixed blood samples and ultrasound evaluations on day 3, 5, 7 and 14 after transvaginal oocyte retrieval

—

Secondary

Measure	Time frame
Secondary end point(s): · number of cumulus-oocyte complexes · number of mature oocytes ;Timepoint(s) of evaluation of this end point: Evaluation of number of cumulus-oocyte complexes and number of mature oocytes on the day of transvaginal oocyte retrieval.	—

Countries

Belgium

Contacts

Public ContactStudy Team

Universitair Ziekenhuis Brussel

IVFstudies@uzbrussel.be0032024776648

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026