FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France

• Conditions: Breast Cancer Female
• Interventions: Other: questionnaires

• Registration Number: NCT03884413
• Lead Sponsor: Institut Curie

Brief Summary

FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

Detailed Description

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...).

Study Timeline

• Study Start: 2018-03-08
• Status Verified: 2018-11
• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1004

Inclusion Criteria

• 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) .

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	questionnaires	Study of spontaneous fertility outcomes in healthy volonteers population
Breast cancer survivors	questionnaires	Study of spontaneous fertility outcomes following breast cancer history

Primary Outcome Measures

Name	Time	Method
Spontaneous pregnancies between cases and controls	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.

Secondary Outcome Measures

Name	Time	Method
Contraceptive prevalence	3 years	Contraceptive use, defined as the percentage of women reporting use of a contraceptive method.
Time to spontaneous pregnancy	3 years	Time to spontaneous pregnancy after breast cancer diagnosis, for women with a desire to become pregnant and trying to get pregnant.
Rate of women considered with risk of unintended pregnancy	3 years	An unwanted pregnancy is defined as unwanted at the time of conception. Women are classified as at risk of unwanted pregnancy if they report having had unprotected sex without a desire to become pregnant in the previous four months.
Percentage of live births obtained by medically assisted procreation procedures	3 years	Percentages live births obtained by ARTs procédures, that include in vitro fertilization (IVF) and embryo transfer (ET), intracytoplasmic sperm injection (ICSI) and ovarian stimulation with exogenous gonadotropins.

Trial Locations

Locations (1)

Seintinelles.Com; 🇫🇷 Paris, France