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临床试验/NCT02355600
NCT02355600Unknown不适用

Tamoxifen as Adjuvant Treatment in Breast Cancer and Its Impact on Ovarian Function

Instituto de Investigacion Sanitaria La Fe1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Metaphase II oocytes retrieved

研究概览

简要总结

Survival in young patients with cancer has increased and also have increased the adverse long-term side effects of chemotherapy, there is a large number of women who experience loss of ovarian function without accomplishing their reproductive desire due to gonadotoxic treatment. The ovarian reserve determine the response to controlled ovarian hyperstimulation in fertility preservation treatments as well as in assisted reproduction techniques. Improving this reserve by avoiding its depletion during the process could result in increase fertility rates after cancer treatment.

Collecting follicles during tamoxifen treatment would increase the number of cryopreserved oocytes and thus rise the potential ovarian reserve in these patients, which is reduced due to age, chemotherapy and length of treatments.

The aim of this study is to retrieve viable mature oocytes during adjuvancy with tamoxifen in breast cancer patients to improve the probability of subsequent pregnancy.

详细描述

New chemotherapy regimens and management options developed during the last 20 years have yielded increased survival rates in cancer patients but they also cause side effects such as premature ovarian failure and infertility due to their gonadotoxicity. Hormone therapy also increases survival rates in breast cancer patients; tamoxifen, a selective estrogen receptor modulator, has been proven to reduce the risk of recurrence and mortality due to breast cancer when administered during 10 years.

The risk of premature ovarian failure depends not only on the gonadotoxicity of chemotherapy but also on the age of the patient, therefore although tamoxifen is not gonadotoxic itself, it can compromise fertility because of the long length of treatment and the subsequent delay in childbearing.

On the other hand, tamoxifen is a drug that can be used in assisted reproduction techniques to induce ovarian stimulation, therefore, the tamoxifen treatment followed by breast cancer patients represent somehow a way of continuous ovarian stimulation. If viable oocytes could be retrieved during the long-term hormonal treatment with tamoxifen, there will be an option to use them to restore fertility afterwards.

STUDY DESIGN:

Patients included in the study who have normal menstrual periods will be monitored by sonography (antral follicle count) and serum hormonal levels: E2 (oestradiol), P4 (progesterone), FSH (follicle stimulating hormone) and LH (luteinizing hormone) from the second day of their cycle. Patients without spontaneous menstruations will perform periodic visits every 15 days until images corresponding with antral follicle definition will be seen, this will be considered day 2 of the cycle.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Breast cancer patients whose tumors have positive hormone receptors (ER+) subsidiary of adjuvant treatment with tamoxifen
  • Reproductive desire

排除标准

  • Having received chemotherapy agents less than 12 months ago
  • Current treatment with GnRH analogues
  • Age > 35 years old
  • Contraindication for follicular punction or hCG administration

结局指标

主要结局

Metaphase II oocytes retrieved

时间窗: 24 months

次要结局

  • Number of frozen embryos(24 months)
  • Morphologic score of frozen embryos(24 months)
  • Pregnancy rate(Expected average of 6 years)

研究者

发起方
Instituto de Investigacion Sanitaria La Fe
申办方类型
Other
责任方
Sponsor

研究点 (1)

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