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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47167

Enrollment

149

Registered

2013-07-31

Start date

2014-01-30

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

breast cancer mamma carcinoma

Interventions

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 r

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Contraindication to study medication Use of medication that opposes effect of study medication Current use of tamoxifen or letrozolr

Design outcomes

Primary

Measure	Time frame
- Number of oocytes retrieved	—

Secondary

Measure	Time frame
- 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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)