FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France

Study Overview
=================
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…).

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

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Other: questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer survivors<br>Study of spontaneous fertility outcomes following breast cancer history | Other: questionnaires<br>* Longitudinal observational study. Collection of health data using self-administered questionnaires online.<br>|
| Control group<br>Study of spontaneous fertility outcomes in healthy volonteers population | Other: questionnaires<br>* Longitudinal observational study. Collection of health data using self-administered questionnaires online.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Contraceptive prevalence | Contraceptive use, defined as the percentage of women reporting use of a contraceptive method. | 3 years | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer survivors,, spontaneous fertility rates,, pregnancy,, birth rate,, chemotherapy-induced infertility