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)
Conditions
Interventions
Trade Name: Elonva
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CORIFOLLITROPIN ALFA
CAS Number: 195962-23-3
Current Sponsor code: G03GA09
Other descriptive name: Elonva
Concentrat
Sponsors
Universitair Ziekenhuis Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age ? 18 and ? 37 years - BMI ? 18 and ? 35 kg/m² - Diagnosis of breast cancer - Presence of 2 ovaries - Signed informed consent form - Medically fit for general anesthesia (ASA score 1-3) - Permission of oncology team (with agreement to postpone chemo/radiotherapy for at least 2 weeks) - Random start controlled ovarian stimulation (follicular or luteal phase) - AFC minimum (ie antral follicles measuring between 2-9 mm): 8 antral folli-cles Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 41 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age 38 years - BMI 35 kg/m² - Difference in AFC between the ovaries of more than 7 antral follicles - Diagnosis of PCOS - Previous radiotherapy and/or chemotherapy (neo-adjuvant chemotherapy included) - Endometriose rAFS 3-4 - Allergy or reaction to the use of Elonva®, Puregon®, Orgalutran®, Ovitrelle®, Gonapeptyl®, Decapeptyl® or letrozole in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This clinical trial will evaluate the impact of an ovarian biopsy on the oocyte metaphase II yield after controlled ovarian stimulation before chemotherapy in view of breast cancer. The purpose of this trial is to learn about the possibility to combine these two fertility preservation procedures without decreasing the number of oocytes collected after an ovarian stimulation.;Secondary Objective: Secondary objectives will be to compare the follicular growth, follicle output rate (FORT), COC yield, maturation rate. ;Primary end point(s): Mature oocyte yield from biopsied versus non-biopsied ovary;Timepoint(s) of evaluation of this end point: Evaluation of number of mature oocytes after denudation of cumulus-oocyte complexes on the day of transvaginal oocyte retrieval | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives will be to compare the follicular growth, follicle output rate (FORT), COC yield, maturation rate. ;Timepoint(s) of evaluation of this end point: Assessment of follicular growth will take place during the ovarian stimulation by performing a transvaginal ultrasound. FORT, COC yield and maturation rate will be assessed on the day of transvaginal oocyte retrieval. | — |
Countries
Belgium
Contacts
Public ContactStudy team
Universitair Ziekenhuis Brussel
Outcome results
None listed