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Triptorelin

Decapeptyl, Trelstar, Gonapeptyl, Pamorelin

Quick Stats
Studies 178
Trials 100
Recruiting PHASE1, PHASE2 INTERVENTIONAL NCT04616729

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed 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. A recent meta-analysis of individual patient data from the largest randomised clinical trials in women with early breast cancer indicated beneficial effects of GnRHa ovarian suppression in reducing POI risk and increasing post-chemotherapy pregnancy rates with no negative effect on patients' outcomes. However, it should not be considered as an alternative to cryopreservation strategies in fertility preservation. 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. Replacement of the 0,2mg triptorelin trigger by a GnRH agonist depot has potential to provide this dual action. 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. Consequently, GnRH agonist-induced stimulation of multiple corpora lutea is potentially unsafe in a patient with breast cancer because of the impact of estradiol and progesterone on breast tumour cells. In addition, VEGF may increase the risk of OHSS, which will lead to postponement of cancer treatment. Therefore, short-term cotreatment with GnRH antagonists is needed to induce rapid luteolysis. 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. 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.

Interventions

Name: Triptorelin 3.75 MG Injection
Type: DRUG
Description: Depot Group (Group A) will receive Triptorelin 3.75mg Depot form for final oocyte maturation.
Name: Transvaginal oocyte retrieval
Type: PROCEDURE
Description: Patients in both groups will undergo a transvaginal oocyte retrieval after ovarian stimulation.
Name: Triptorelin Injection
Type: DRUG
Description: Daily Group (Group B) will receive Triptorelin 0.2mg Daily form for final oocyte maturation.

Primary Outcomes

Measure: 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)
Description: A transvaginal ultrasound will be performed to measure the ovarian volume according to the formula 'length x width x height x 0.523' mm³. In the assumption of safety ovarian volume should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: 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)
Description: A blood sample will be taken to evaluate hematocrit (%). In the assumption of safety hematocrit levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: 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)
Description: A blood sample will be taken to evaluate hemoglobine (g/dL). In the assumption of safety hemoglobine levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: 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)
Description: A blood sample will be taken to evaluate White Blood cell Count (X10³/mm³). In the assumption of safety White Blood cell Count should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: 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)
Description: A blood sample will be taken to evaluate Platelet Count (X10³/mm³). In the assumption of safety Platelet Count should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: 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)
Description: A blood sample will be taken to evaluate eGFR (mL/min/1.73m²). In the assumption of safety eGFR levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: Safety profile with regard to the risk of OHSS: assessment of change in Creatinine
TimeFrame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
Description: A blood sample will be taken to evaluate Creatinine (mg/dL). In the assumption of safety creatinine levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: Safety profile with regard to the risk of OHSS: assessment of change in Albumin
TimeFrame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
Description: A blood sample will be taken to evaluate Albumin (g/L). In the assumption of safety Albumin levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: Safety profile with regard to the risk of OHSS: assessment of change in liver function (AST, ALT, Gamma-GT, bilirubine, LDH)
TimeFrame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
Description: A blood sample will be taken to evaluate liver function (AST U/L, ALT U/L, Gamma-GT U/L, bilirubine mg/dL, LDH U/L). In the assumption of safety liver function levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: Safety profile with regard to the risk of OHSS: assessment of change in Oestradiol (E2)
TimeFrame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
Description: A blood sample will be taken to evaluate Oestradiol (ng/L). In the assumption of safety Oestradiol levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: Safety profile with regard to the risk of OHSS: assessment of change in Progesteron
TimeFrame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
Description: A blood sample will be taken to evaluate Progesteron (mcg/L). In the assumption of safety Progesteron levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: Safety profile with regard to the risk of OHSS: assessment of change in Follicle Stimulating Hormone (FSH)
TimeFrame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
Description: A blood sample will be taken to evaluate FSH (IU/L). In the assumption of safety FSH levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.
Measure: Safety profile with regard to the risk of OHSS: assessment of change in Luteinizing Hormone (LH)
TimeFrame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
Description: A blood sample will be taken to evaluate LH (IU/L). In the assumption of safety LH levels should be similar to that in the control group and there should be no events of ovarian hyperstimulation syndrome.

Trial Information

NCT ID

NCT04616729

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

Universitair Ziekenhuis Brussel

Last Updated

December 15, 2025

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