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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).

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). - TAMOXI project

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35875
Enrollment
10
Registered
2012-11-20
Start date
2011-02-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breastcancer mammary carcinoma

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the serum endoxifen level during the whole period of ovarian hyperstimulation. The endoxifen level is a binary outcome measure, a level

Secondary

MeasureTime frame
Baseline characteristics, ovarian hyperstimulation, the resulting number and quality of embryos and oocytes frozen. Data with regard to the cycle day, hour of tamoxifen intake and the hour of blood sample and follicle-fluid collections for measurement of active tamoxifen-metabolites are collected as well.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)