The effectiveness of controlled ovarian stimulation in women with breast cancer
Phase 1
- Conditions
- Ovarian stimulation in women with breast cancer prior to chemotherapyTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000801-21-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 159
Inclusion Criteria
Age 18 – 43 years
Confirmed breast cancer (ER+, ER- or unknown ER status)
Candidate for oocyte or embryo banking (as approved by referring breast cancer specialist and the centre for reproductive medicine that the women is referred to)
Willing and able to give informed consent
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 159
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Contraindication to study medication
Use of medication that opposes effect of study medication
Current use of tamoxifen or letrozole
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effectiveness of controlled ovarian stimulation (COS) with tamoxifen or letrozole in terms of oocyte yield compared to standard COS for oocyte- or embryo banking in women with breast cancer. ;Secondary Objective: Not applicable;Primary end point(s): -number of oocytes retrieved at follicle aspiration. ;Timepoint(s) of evaluation of this end point: day of follicle aspiration
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - number of mature oocytes retrieved<br>- number of oocytes or embryos banked <br>- peak E2 levels during COS;Timepoint(s) of evaluation of this end point: 4-6 days after follicle aspiration