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临床试验/NCT03884413
NCT03884413已完成不适用

FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France: the FEERIC Study

Institut Curie1 个研究点 分布在 1 个国家目标入组 517 人开始时间: 2018年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
517
试验地点
1
主要终点
Spontaneous pregnancies between cases and controls

研究概览

简要总结

FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

详细描述

Breast cancer is the most common cancer among women. With the increase of the survival rates, a growing attention is paid to the side effects of the treatments, particularly chemotherapy-induced infertility.

The FEERIC study will give insights into spontaneous fertility outcomes following breast cancer in comparison with a control cohort and will provide data to help patients counselling towards spontaneous fertility rates following breast cancer. It will also provide data on contraceptive prevalence and unintended pregnancy rates in French breast cancer survivors. Reasons for unmet need for family planning will be deciphered, in order to point out pitfalls (lack of patient's information or orientation/ignorance of contraception methods available/topic insufficiently or not discussed with the physician/ lack of family planning offer etc...); and target the appropriate actions to lead (oncologist and oncology nurses education/ dedicated consultations in breast cancer centers/etc...).

研究设计

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

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • females aged from 18 to 43 at inclusion
  • previous diagnosis of breast cancer and time from diagnosis comprised between one and five years or women free from breast cancer or other malignancy (healthy volunteers) .

排除标准

  • hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy
  • healthy volonteer with history of malignant disease.

结局指标

主要结局

Spontaneous pregnancies between cases and controls

时间窗: 3 years

Odds ratio between the spontaneous pregnancies between cases and controls, for women with a desire to become pregnant and trying to get pregnant.

次要结局

  • Time to spontaneous pregnancy(3 years)
  • Contraceptive prevalence(3 years)
  • Rate of women considered with risk of unintended pregnancy(3 years)
  • Percentage of live births obtained by medically assisted procreation procedures(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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