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the STIM-trial

Stimulation of the ovaries in women with breast cancer undergoing fertility preservation: alternative versus standard stimulation protocols; the STIM-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21429
Enrollment
159
Registered
2013-08-06
Start date
2013-08-12
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

breast cancer, controlled ovarian stimulation, estradiol, tamoxifen, letrozole. borstkanker, ovariele stimulatie, oestradiol, tamoxifen, letrozol.

Interventions

Group 1 will receive tamoxifen (60 mg per day, orally) in addition to COS. Group 2 will receive letrozoel (5 mg per day, orally) in addition to COS. Group 3 will undergo standard COS with no additiona

Sponsors

Academical Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age 18 – 43 years - Confirmed breast cancer (ER+, ER- or unknown ER status) - Candidate for oocyte or embryocryopreservation (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

Exclusion criteria

Exclusion criteria: - Contraindication to study medication - Use of medication that opposes effect of study medication

Design outcomes

Primary

MeasureTime frame
Primary outcome is number of oocytes retrieved at follicle apsiration.

Secondary

MeasureTime frame
- Number of mature oocytes retrieved - Number of oocytes or embryos banked - Peak E2 levels during COS defined as serum E2 level measured on the day of ovulation trigger

Contacts

Public ContactM. Goddijn

Academic medical centre, location Q3-120 Postbus 22660

M.Goddijn@amc.uva.nl+31 (0)20 5663557

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)