The effectiveness of controlled ovarian stimulation in women with breast cancer

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000801-21-NL

Enrollment

159

Registered

2013-08-12

Start date

2014-08-26

Completion date

Unknown

Last updated

2018-06-05

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

Conditions

Ovarian stimulation in women with breast cancer prior to chemotherapy

Interventions

Trade Name: Tamoxifen Pharmaceutical Form: Tablet Trade Name: Letrozole Product Name: Letrozole Product Code: RVG 105802 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 – 43 years Confirmed breast cancer (ER+, ER- or unknown ER status) Candidate for oocyte or embryo banking (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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 159 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effectiveness of controlled ovarian stimulation (COS) with tamoxifen or letrozole in terms of oocyte yield compared to standard COS for oocyte- or embryo banking in women with breast cancer. ;Secondary Objective: Not applicable;Primary end point(s): -number of oocytes retrieved at follicle aspiration. ;Timepoint(s) of evaluation of this end point: day of follicle aspiration	—

Measure

Time frame

Main Objective: To evaluate the effectiveness of controlled ovarian stimulation (COS) with tamoxifen or letrozole in terms of oocyte yield compared to standard COS for oocyte- or embryo banking in women with breast cancer. ;Secondary Objective: Not applicable;Primary end point(s): -number of oocytes retrieved at follicle aspiration. ;Timepoint(s) of evaluation of this end point: day of follicle aspiration

—

Secondary

Measure	Time frame
Secondary end point(s): - number of mature oocytes retrieved - number of oocytes or embryos banked - peak E2 levels during COS;Timepoint(s) of evaluation of this end point: 4-6 days after follicle aspiration	—

Countries

Belgium, Netherlands, United Kingdom

Contacts

Public ContactAMR

Academic Medical Center

0031205669111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026