About this trial
Latrogenic infertility as a result of cancer treatment has a profound effect on long-term quality of life in survivors of reproductive-age cancers. Oocyte cryopreservation prior to cancer treatment has been associated with improved quality of life, with a potential ability to reduce long-term decision-related regret in cancer survivors. Though letrozole plus gonadotropin and and tamoxifen plus gonadotropin are currently routinely used worldwide in ovarian stimulation cycles for fertility preservation in patients with estrogen-receptor-positive breast cancer, it is not clear which of the two might lead to improved oocyte yield. Improved knowledge about the efficacy of these medications, with regard to oocyte yield, has the potential to significantly improve quality of life in reproductive-age breast cancer survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
New breast cancer diagnosis
Has not yet begun chemotherapy
Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
Age 18 years old or greater
Disqualifiers
Chemotherapy has already commenced or been completed
History of recurrent breast cancer (with a prior history of chemotherapy)
Stage IV breast cancer diagnosis (metastases remote from the breast)
Patient's oncologist advises against the trial - in which case they can choose to receive stimulation with letrozole+gonadotropin
Trial design
Parallel
Treatments tested in this trial
Tamoxifen
DrugGiven orally
Letrozole
DrugGiven orally
Treatment groups
Trial outcomes
Primary outcomes
Mature Oocyte Yield
To determine if the assigned stimulation regimen will result in a difference in mature (meiosis II) oocyte yield in patients with breast cancer who undergo ovarian stimulation for fertility preservation. An Effect Size of 3 mature oocytes, based on clinically significant difference of 2 embryos to transfer. An average of 2 embryos are transferred per freeze-thaw cycle. If \~75% of mature oocytes will become embryos that can be frozen, then 3 mature oocytes should yield \~2 embryos for transfer. This effect size would effectively mean an additional event of embryos transferred.
Secondary outcomes
Compare change in estrogen levels during the ovarian stimulation cycle
Estrogen level data will be collected at baseline and after completion of the stimulation cycle
Compare change in progesterone levels during the ovarian stimulation cycle
Progesterone level data will be collected at baseline and after completion of the stimulation cycle
Compare change in androgen levels during the ovarian stimulation cycle
Androgen level data will be collected at baseline and after completion of the stimulation cycle
Compare change in estrogen in follicular fluid
Estrogen levels in follicular fluid will be collected at baseline and after completion of the stimulation cycle
Sponsors and contacts
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