FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France

Breast Cancer Female Clinical Trial

— FEERIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03884413
• Other study ID #: IC 2016-07
• Status: Recruiting
• Start date: March 8, 2018
• Est. completion date: March 2021

Study information

• Verified date: November 2018
• Source: Institut Curie
• Contact: Laura SABLONE
• Phone: 06.07.44.74.36
• Email: laura.sablone[@]seintinelles.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

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…).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1004
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• questionnaires
Longitudinal observational study. Collection of health data using self-administered questionnaires online.

Locations

Country	Name	City	State
France	Seintinelles.Com	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Curie	seintinelles network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous pregnancies between cases and controls	Odds ratio between the spontaneous pregnancies between cases and controls, for women with a desire to become pregnant and trying to get pregnant.	3 years
Secondary	Time to spontaneous pregnancy	Time to spontaneous pregnancy after breast cancer diagnosis, for women with a desire to become pregnant and trying to get pregnant.	3 years
Secondary	Contraceptive prevalence	Contraceptive use, defined as the percentage of women reporting use of a contraceptive method.	3 years
Secondary	Rate of women considered with risk of unintended pregnancy	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.	3 years
Secondary	Percentage of live births obtained by medically assisted procreation procedures	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.	3 years