Ovarian hyperstimulation in women with estrogen-receptor positive breastcancer who opt for embryo- or oocyte freezing: Is the Tamoxifen dosage sufficient to protect women against estrogen exposure? (TAMOXI project: a pilot study).
- Conditions
- breastcancermammary carcinoma1000629110018515
- Registration Number
- NL-OMON35875
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Women who are of reproductive age (18- 40 yrs), who suffer from estrogen- receptor positive breast cancer and opt for embryo- or oocyte freezing.
Exclusion Criteria
1)Women who are unwilling or unable to sign the informed consent form
2)Women who are not in good enough medical condition to undergo ovarian hormone stimulation and ovum pick up.
3) Women who need medication which opposes the efficacy of tamoxifen (e.g. fluotexine)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of the study is the serum endoxifen level during the whole<br /><br>period of ovarian hyperstimulation.<br /><br><br /><br>The endoxifen level is a binary outcome measure, a level < 7 ng/ml = supposed<br /><br>to be insufficient E2 blockade. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Baseline characteristics, ovarian hyperstimulation, the resulting number and<br /><br>quality of embryos and oocytes frozen. Data with regard to the cycle day, hour<br /><br>of tamoxifen intake and the hour of blood sample and follicle-fluid collections<br /><br>for measurement of active tamoxifen-metabolites are collected as well. </p><br>