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the STIM-trial


- candidate number15245
- NTR NumberNTR4108
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-aug-2013
- Secondary IDs43808 
- Public Titlethe STIM-trial
- Scientific TitleStimulation of the ovaries in women with breast cancer undergoing fertility preservation: alternative versus standard stimulation protocols; the STIM-trial
- ACRONYMSTIM-trial
- hypothesisA low peak E2 during COS is considered to be safer than a high peak E2 in women with breast cancer
- Healt Condition(s) or Problem(s) studiedBreast cancer, Ovarian stimulation, Tamoxifen, Letrozole, Estradiol
- 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- Contraindication to study medication
- Use of medication that opposes effect of study medication
- Pregnancy or lactation
- Recent chemotherapy
- Liver- or kidney failure
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-aug-2013
- planned closingdate31-dec-2016
- Target number of participants159
- InterventionsGroup 1 will receive tamoxifen (60 mg per day, orally) in addition to COS. Group 2 will receive letrozoel (2,5 mg per day, orally) in addition to COS. Group 3 will undergo standard COS with no additional treatment.
- Primary outcomePrimary outcome is peak E2 levels defined as serum E2 level measured on the day of ovulation trigger (day of GnRHa injection).
- Secondary outcome- Levels of tamoxifen metabolites (only in women randomised to use tamoxifen
- Quantity oocytes retrieved
- Number of mature oocytes
- Quantity and quality of embryo’s cryopreserved
- 5-year breast cancer free interval
- 5-year survival
-10-year breast cancer free interval
-10-year survival
- Uptake of oocytes or embryos
- Ongoing pregnancy rate
- Pregnancy outcomes
- Congenital malformations
- Timepoints1. during COS at day of ovulation trigger with GnRHa
2. day of OPU (number of cryopreserved embryo's or oocytes)
3. 1 year after randomisation
4. 5 years after randomisation
4. 10 years after randomisation
5. during pregnancy after uptake of embryo's or oocytes.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M. Goddijn
- CONTACT for SCIENTIFIC QUERIESDr. M. Goddijn
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Pink Ribbon
- PublicationsN/A
- Brief summaryRaionale:Chemotherapy for breast cancer may have a negative impact on reproductive function due to gonadotoxic damage. Fertility preservation via banking of oocytes or embryos after controlled ovarian stimulation with FSH (COS) may increase the likelihood of a future successful pregnancy. It has been hypothesized that elevated serum estrogen levels during COS may induce growth of breast tumours. This has led to the use of alternative COS protocols with addition of tamoxifen or letrozole. The effectiveness of these COS protocols in terms of oocyte yield is unknown.

Objective:To evaluate the effectiveness of COS with tamoxifen or letrozole in terms of oocyte yield compared to standard COS for oocyte- or embryo banking.

Study design:Randomized open-label trial comparing COS plus tamoxifen and COS plus letrozole with standard COS in the course of fertility preservation.

Study population:Women with breast cancer who opt for banking of oocytes or embryos, aged 18 – 43 years at randomisation.

Intervention : Women will receive tamoxifen 60 mg per day orally in combination with COS or letrozole 5 mg per day orally in combination with COS, or standard COS.

Main study parameters/endpoints: Primary outcome: the number of oocytes retrieved at follicle aspiration. Secondary outcomes are number of mature oocytes retrieved, number of oocytes or embryos banked and peak E2 levels during COS.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:All women will undergo one additional blood sample on the day of ovulation trigger for E2 measurement. If measurement of anti-mullerian hormone (AMH) is not part of standard care, one extra blood sample will be drawn for AMH measurement. In the women who receive tamoxifen in addition to COS, in some centres (Academic Medical Center Amsterdam and University hospital Brussels a series of four to six measurements of tamoxifen metabolites will be analysed in blood samples acquired during routine blood sampling for COS.
- Main changes (audit trail)21-mei-2015: Multiple changes-EB Titel:
Old: The safety of controlled ovarian stimulation in women with breast cancer: standard stimulation versus alternative stimulation protocols; the STIM-trial
New: Stimulation of the ovaries in women with breast cancer undergoing fertility preservation: alternative versus standard stimulation protocols; the STIM-trial

Exclusion criteria:
Old: - Contraindication to study medication
- Use of medication that opposes effect of study medication
- Pregnancy or lactation
- Recent chemotherapy - Liver- or kidney failure
New:
- Contraindication to study medication
- Use of medication that opposes effect of study medication

Intervention:
Old:Group 1 will receive tamoxifen (60 mg per day, orally) in addition to COS. Group 2 will receive letrozoel (2,5 mg per day, orally) in addition to COS. Group 3 will undergo standard COS with no additional treatment.
New:
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 additional treatment.

Primary outcome:
Old:Primary outcome is peak E2 levels defined as serum E2 level measured on the day of ovulation trigger (day of GnRHa injection).
New: Primary outcome is number of oocytes retrieved at follicle apsiration.

Secondary outcome:
Old:- Levels of tamoxifen metabolites (only in women randomised to use tamoxifen
- Quantity oocytes retrieved
- Number of mature oocytes
- Quantity and quality of embryo’s cryopreserved 
- 5-year breast cancer free interval
- 5-year survival
-10-year breast cancer free interval
-10-year survival
- Uptake of oocytes or embryos
- Ongoing pregnancy rate
- Pregnancy outcomes
- Congenital malformations
New:
- 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

Timepoints:
Old:
1. during COS at day of ovulation trigger with GnRHa
2. day of OPU (number of cryopreserved embryo's or oocytes)
3. 1 year after randomisation
4. 5 years after randomisation
4. 10 years after randomisation
5. during pregnancy after uptake of embryo's or oocytes.
New:
1. during COS at day of ovulation trigger with GnRHa
2. day of OPU (number of cryopreserved embryo's or oocytes)
- RECORD6-aug-2013 - 21-mei-2015


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