Breast Cancer FemalePhase 1/2Depo-TriggerNCT04616729
DEPO-Trigger Trial: GnRH Agonist DEPOt TRIGGER for Final Oocyte Maturation
A Phase 1/2 study testing Triptorelin 3.75 MG Injection, Transvaginal oocyte retrieval and Triptorelin Injection in people with Breast Cancer Female, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Triptorelin 3.75 MG Injection, Transvaginal oocyte retrieval and Triptorelin Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Nov 2022to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Contra-indications for controlled ovarian stimulation or oocyte retrieval
- Necessity of neo-adjuvant chemotherapy
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Boortmeerbeek, Brussels Capital, 3190
Michel De Vos, MD, 024776660 ext. 0032, mdv@uzbrussel.be
Michel De Vos, 024776660, mdv@uzbrussel.be
- Not yet recruiting
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, 3000
Sharon Lie Fong, MD PhD, 016343650 ext. 0032
About this study
Official title: DEPO-Trigger Trial: GnRH Agonist DEPOt TRIGGER for Final Oocyte Maturation in Breast Cancer Patients Undergoing Fertility Preservation: a Pilot Study
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.
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- Triptorelin 3.75 MG Injection, Transvaginal oocyte retrieval, Triptorelin Injection
- Keywords
- Fertility preservation, Reproductive Techniques, assisted, Ovulation Induction, Oocyte Retrieval, Cryopreservation
- Medical subject headings
- Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin 3.75 MG InjectionDrug
Also called Gonapeptyl, Decapeptyl
Depot Group (Group A) will receive Triptorelin 3.75mg Depot form for final oocyte maturation.
Transvaginal oocyte retrievalProcedure or surgery
Patients in both groups will undergo a transvaginal oocyte retrieval after ovarian stimulation.
Triptorelin InjectionDrug
Also called Gonapeptyl, Decapeptyl
Daily Group (Group B) will receive Triptorelin 0.2mg Daily form for final oocyte maturation.
| Study group | Role | What they receive |
|---|---|---|
| GnRH agonist Depot form | Experimental | Ovarian stimulation will be performed using a fixed antagonist protocol with Follitropin Alfa (daily in the evening) and Ganirelix or Cetrorelix (daily in the morning). Selection of the daily gonadotropin dose will be based on ovarian reserve parameters (AMH and AFC) and BMI. Co-administration of 5 mg of letrozole daily (in the morning) commencing on the first day of gonadotropin administration and continuing throughout the ovarian stimulation will be performed as this reduces oestradiol concentrations. GnRH agonist Triptorelin 3.75 mg Depot form will be used for final oocyte maturation. Ganirelix/Cetrorelix 0.25mg daily (in the morning) will resume for 7 days from the evening of the day of oocyte retrieval onwards. Hormone analysis, analysis of haematology and biochemistry and a pelvic ultrasound scan will be done on days 3, 5 and 7 after oocyte retrieval. Receives: Drug: Triptorelin 3.75 MG Injection; Procedure: Transvaginal oocyte retrieval |
| GnRH agonist Daily form | Active comparator | Ovarian stimulation will be performed using a fixed antagonist protocol with Follitropin Alfa (daily in the evening) and Ganirelix/Cetrorelix (daily in the morning). Selection of the daily gonadotropin dose will be based on ovarian reserve parameters (AMH and AFC) and BMI. Co-administration of 5 mg of letrozole daily (in the morning) commencing on the first day of gonadotropin administration and continuing throughout the ovarian stimulation will be performed as this reduces oestradiol concentrations. GnRH agonist Triptorelin 0.2 mg Daily form will be used for final oocyte maturation. Hormone analysis, analysis of haematology and biochemistry and a pelvic ultrasound scan will be done on days 3, 5 and 7 after oocyte retrieval. The first administration of Triptorelin 3.75mg depot will be scheduled on the first day of the menstrual cycle after oocyte retrieval. To prevent the flare-up produced by the GnRH agonist, daily doses of 0.25mg of Ganirelix/Cetrorelix will be given for seven days. Receives: Procedure: Transvaginal oocyte retrieval; Drug: Triptorelin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile with regard to the risk of OHSS: assessment of change in ovarian volume
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
Secondary outcomes (3)
Number of cumulus-oocyte complexes
Evaluation of the number of cumulus-oocyte complexes between the Depot Group and Daily Group
Measured: During the procedure of the transvaginal oocyte retrieval
Number of Metaphase II oocytes
Evaluation of the number of Metaphase II oocytes between the Depot group and Daily group
Measured: Immediately after the procedure of the transvaginal oocyte retrieval
Evaluation of climacteric symptoms
Assessment of MENQOL (The Menopause-Specific Quality of Life) Questionnaire
Measured: One week after the transvaginal oocyte retrieval (on day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Nov 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. Group A will receive the GnRH agonist Depot form for final oocyte maturation followed by daily GnRH antagonist injections for 1 week. Group 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. Blood analysis and ultrasounds will be organised on day 3, 5 and 7 after oocyte pick-up in both groups.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Michel De Vos, MD PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616729
- Sponsor's protocol ID
- 2019DEPO-TRIGGER001
- Acronym
- Depo-Trigger
- Status last verified
- Apr 2023
- First submitted
- 21 Oct 2020
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As this is a multicenter study, we plan to share IPD between the study sites. An electronically case report form (eCRF) will be set up and completed in all sites. Data will be handled in accordance with the general data protection regulation (GDPR).
Publications
Lambertini M, Cinquini M, Moschetti I, Peccatori FA, Anserini P, Valenzano Menada M, Tomirotti M, Del Mastro L. Temporary ovarian suppression during chemotherapy to preserve ovarian function and fertility in breast cancer patients: A GRADE approach for evidence evaluation and recommendations by the Italian Association of Medical Oncology. Eur J Cancer. 2017 Jan;71:25-33. doi: 10.1016/j.ejca.2016.10.034. Epub 2016 Dec 9.
PubMed 27940355Lambertini M, Moore HCF, Leonard RCF, Loibl S, Munster P, Bruzzone M, Boni L, Unger JM, Anderson RA, Mehta K, Minton S, Poggio F, Albain KS, Adamson DJA, Gerber B, Cripps A, Bertelli G, Seiler S, Ceppi M, Partridge AH, Del Mastro L. Gonadotropin-Releasing Hormone Agonists During Chemotherapy for Preservation of Ovarian Function and Fertility in Premenopausal Patients With Early Breast Cancer: A Systematic Review and Meta-Analysis of Individual Patient-Level Data. J Clin Oncol. 2018 Jul 1;36(19):1981-1990. doi: 10.1200/JCO.2018.78.0858. Epub 2018 May 2.
PubMed 29718793
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEPO-Trigger Trial: GnRH Agonist DEPOt TRIGGER for Final Oocyte Maturation in Breast Cancer Patients Undergoing Fertility Preservation: a Pilot Study
- ClinicalTrials.gov ID
- NCT04616729
- Acronym / sponsor ID
- Depo-Trigger / 2019DEPO-TRIGGER001
- Conditions
- Breast Cancer Female
- Keywords
- Fertility preservation, Reproductive Techniques, assisted, Ovulation Induction, Oocyte Retrieval, Cryopreservation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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. Group A will receive the GnRH agonist Depot form for final oocyte maturation followed by daily GnRH antagonist injections for 1 week. Group 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. Blood analysis and ultrasounds will be organised on day 3, 5 and 7 after oocyte pick-up in both groups.
| Arm | Type | Receives |
|---|---|---|
| GnRH agonist Depot form | Experimental | Drug: Triptorelin 3.75 MG Injection, Procedure: Transvaginal oocyte retrievalOvarian stimulation will be performed using a fixed antagonist protocol with Follitropin Alfa (daily in the evening) and Ganirelix or Cetrorelix (daily in the morning). Selection of the daily gonadotropin dose will be based on ovarian reserve parameters (AMH and AFC) and BMI. Co-administration of 5 mg of letrozole daily (in the morning) commencing on the first day of gonadotropin administration and continuing throughout the ovarian stimulation will be performed as this reduces oestradiol concentrations. GnRH agonist Triptorelin 3.75 mg Depot form will be used for final oocyte maturation. Ganirelix/Cetrorelix 0.25mg daily (in the morning) will resume for 7 days from the evening of the day of oocyte retrieval onwards. Hormone analysis, analysis of haematology and biochemistry and a pelvic ultrasound scan will be done on days 3, 5 and 7 after oocyte retrieval. |
| GnRH agonist Daily form | Active comparator | Procedure: Transvaginal oocyte retrieval, Drug: Triptorelin InjectionOvarian stimulation will be performed using a fixed antagonist protocol with Follitropin Alfa (daily in the evening) and Ganirelix/Cetrorelix (daily in the morning). Selection of the daily gonadotropin dose will be based on ovarian reserve parameters (AMH and AFC) and BMI. Co-administration of 5 mg of letrozole daily (in the morning) commencing on the first day of gonadotropin administration and continuing throughout the ovarian stimulation will be performed as this reduces oestradiol concentrations. GnRH agonist Triptorelin 0.2 mg Daily form will be used for final oocyte maturation. Hormone analysis, analysis of haematology and biochemistry and a pelvic ultrasound scan will be done on days 3, 5 and 7 after oocyte retrieval. The first administration of Triptorelin 3.75mg depot will be scheduled on the first day of the menstrual cycle after oocyte retrieval. To prevent the flare-up produced by the GnRH agonist, daily doses of 0.25mg of Ganirelix/Cetrorelix will be given for seven days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age <36y
- BMI ≥ 18 and ≤ 35 kg/m²
- Early stage breast cancer
- Any hormone receptor status
- Any HER status
Key exclusion criteria (2 listed)
- Contra-indications for controlled ovarian stimulation or oocyte retrieval
- Necessity of neo-adjuvant chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin 3.75 MG InjectionAlso: Gonapeptyl, DecapeptylDepot Group (Group A) will receive Triptorelin 3.75mg Depot form for final oocyte maturation. | Drug | GnRH agonist Depot form |
| Transvaginal oocyte retrievalPatients in both groups will undergo a transvaginal oocyte retrieval after ovarian stimulation. | Procedure or surgery | GnRH agonist Daily form, GnRH agonist Depot form |
| Triptorelin InjectionAlso: Gonapeptyl, DecapeptylDaily Group (Group B) will receive Triptorelin 0.2mg Daily form for final oocyte maturation. | Drug | GnRH agonist Daily form |
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)
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.
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)
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.
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)
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.
Safety profile with regard to the risk of OHSS: assessment of change in White Blood cell Count
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
Safety profile with regard to the risk of OHSS: assessment of change in Platelet Count
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
Safety profile with regard to the risk of OHSS: assessment of change in estimated glomerular filtration rate (eGFR)
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
Safety profile with regard to the risk of OHSS: assessment of change in Creatinine
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
Safety profile with regard to the risk of OHSS: assessment of change in Albumin
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
Safety profile with regard to the risk of OHSS: assessment of change in liver function (AST, ALT, Gamma-GT, bilirubine, LDH)
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
Safety profile with regard to the risk of OHSS: assessment of change in Oestradiol (E2)
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
Safety profile with regard to the risk of OHSS: assessment of change in Progesteron
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
Safety profile with regard to the risk of OHSS: assessment of change in Follicle Stimulating Hormone (FSH)
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
Safety profile with regard to the risk of OHSS: assessment of change in Luteinizing Hormone (LH)
Time frame: During one week after the transvaginal oocyte retrieval (on day 3, 5 and 7)
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.
3 secondary outcomes
Number of cumulus-oocyte complexes
Time frame: During the procedure of the transvaginal oocyte retrieval
Number of Metaphase II oocytes
Time frame: Immediately after the procedure of the transvaginal oocyte retrieval
Evaluation of climacteric symptoms
Time frame: One week after the transvaginal oocyte retrieval (on day 7)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 27940355Lambertini M, Cinquini M, Moschetti I, Peccatori FA, Anserini P, Valenzano Menada M, Tomirotti M, Del Mastro L. Temporary ovarian suppression during chemotherapy to preserve ovarian function and fertility in breast cancer patients: A GRADE approach for evidence evaluation and recommendations by the Italian Association of Medical Oncology. Eur J Cancer. 2017 Jan;71:25-33. doi: 10.1016/j.ejca.2016.10.034. Epub 2016 Dec 9.
- Background: PubMed 29718793Lambertini M, Moore HCF, Leonard RCF, Loibl S, Munster P, Bruzzone M, Boni L, Unger JM, Anderson RA, Mehta K, Minton S, Poggio F, Albain KS, Adamson DJA, Gerber B, Cripps A, Bertelli G, Seiler S, Ceppi M, Partridge AH, Del Mastro L. Gonadotropin-Releasing Hormone Agonists During Chemotherapy for Preservation of Ovarian Function and Fertility in Premenopausal Patients With Early Breast Cancer: A Systematic Review and Meta-Analysis of Individual Patient-Level Data. J Clin Oncol. 2018 Jul 1;36(19):1981-1990. doi: 10.1200/JCO.2018.78.0858. Epub 2018 May 2.
- Individual participant dataSharing planned: Yes. As this is a multicenter study, we plan to share IPD between the study sites. An electronically case report form (eCRF) will be set up and completed in all sites. Data will be handled in accordance with the general data protection regulation (GDPR).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel De Vos, MD PhD principal investigator
Universitair Ziekenhuis Brussel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Triptorelin 3.75 MG Injection, Transvaginal oocyte retrieval and Triptorelin Injection in people with Breast Cancer Female, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel De Vos, MD PhD (024776660 ext. 0032, mdv@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616729, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023; AzTrials last refreshed its copy on 26 Oct 2026.