To evaluate the effects of COS with tamoxifen or letrozole compared to standard COS, on oocytes retrieved.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Gonadotrophin and sex hormone changes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Number of oocytes retrieved
Secondary outcome
- Number of mature (metaphase II) oocytes
- Number of oocytes or embryo''s cryopreserved
- Peak estradiol levels during COS (measured at the day of ovulation trigger).
- Levels of active tamoxifen metabolites (only in women randomised to use
tamoxifen)
- Data regarding long-term outcomes will be collected but is not part of
current studyprotocol.
Background summary
Chemotherapy for breast cancer may have a negative impact on reproductive
function due to gonadotoxic damage. Cryopreservation of oocytes or embryos
after IVF with controlled ovarian stimulation with FSH (COS) may increase the
likelihood of future successful pregnancy, when this is performed prior to
chemotherapy. It has been hypothesized that elevated estrogen levels during
COS may induce growth of hormone sensitive tumours. This has led to the use of
alternative COS protocols with addition of tamoxifen or letrozole. The idea is
that these agents reduce oestradiol levels during COS. It is unknown if
stimulation protocols with additional agents influence the oocyte retrieved.
The aim of this study is to evaluate the effectiveness of COS with tamoxifen or
letrozole compared to standard COS in women with breast cancer who opt for
oocyte- or embryocryopreservation.
Study objective
To evaluate the effects of COS with tamoxifen or letrozole compared to
standard COS, on oocytes retrieved.
Study design
Randomized open-label trial comparing COS with additional tamoxifen or
letrozole with standard COS.
Intervention
The first group of women will receive standard COS with tamoxifen 60 mg per day
orally. The second group of women will receive standard COS with Letrozole 5 mg
per day orally. The third group will receive standard COS
Study burden and risks
All women will undergo one additional blood sample on the day of ovum pick up
for estradiol (E2) measurement. In the women who receive tamoxifen in addition
to standard COS, a series of four to six measurements of tamoxifen metabolites
will be analysed in bloodsamples aquired during routine bloodsampling for COS.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Age 18 * 43 years
Confirmed breast cancer (ER+, ER- or unknown ER status)
Candidate for (neo) adjuvant chemotherapy
Opting for embryo- or oocyte cryopreservation
Willing and able to give informed consent
Exclusion criteria
Contraindication to study medication
Use of medication that opposes effect of study medication
Current use of tamoxifen or letrozolr
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-000801-21-NL |
| CCMO | NL43808.018.13 |