Clinical trial

DEPO-Trigger Trial: GnRH Agonist DEPOt TRIGGER for Final Oocyte Maturation in Breast Cancer Patients Undergoing Fertility Preservation: a Pilot Study

ID

Name

2019DEPO-TRIGGER001

Description

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.

Trial arms

Trial start

2022-11-01

Estimated PCD

2025-11-30

Trial end

2025-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Triptorelin 3.75 MG Injection

Depot Group (Group A) will receive Triptorelin 3.75mg Depot form for final oocyte maturation.

Arms:

GnRH agonist Depot form

Other names:

Gonapeptyl, Decapeptyl

Transvaginal oocyte retrieval

Patients in both groups will undergo a transvaginal oocyte retrieval after ovarian stimulation.

Arms:

GnRH agonist Daily form, GnRH agonist Depot form

Triptorelin Injection

Daily Group (Group B) will receive Triptorelin 0.2mg Daily form for final oocyte maturation.

Arms:

GnRH agonist Daily form

Other names:

Gonapeptyl, Decapeptyl

Size

30

Primary endpoint

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

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

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

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

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

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)

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

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 Albumin

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 liver function (AST, ALT, Gamma-GT, bilirubine, LDH)

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 Oestradiol (E2)

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 Progesteron

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 Follicle Stimulating Hormone (FSH)

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 Luteinizing Hormone (LH)

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

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized before start of ovarian 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.\n\nGroup A will receive the GnRH agonist Depot form for final oocyte maturation followed by daily GnRH antagonist injections for 1 week.\n\nGroup B will receive the GnRH agonist daily form for final oocyte maturation. After one week the Depot form combined with daily GnRH antagonist injections for 7 days, will be administered in view of ovarian protection during chemotherapy.\n\nBlood analysis and ultrasounds will be organised on day 3, 5 and 7 after oocyte pick-up in both groups.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-05-18

1 organization

1 product

1 indication

Organization

Universitair Ziekenhuis Brussel

Product

Indication