- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03884413
FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France (FEERIC)
FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France: the FEERIC Study
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France
- Seintinelles.Com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Breast cancer survivors
Study of spontaneous fertility outcomes following breast cancer history
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Longitudinal observational study.
Collection of health data using self-administered questionnaires online.
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Control group
Study of spontaneous fertility outcomes in healthy volonteers population
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Longitudinal observational study.
Collection of health data using self-administered questionnaires online.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spontaneous pregnancies between cases and controls
Time Frame: 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.
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3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to spontaneous pregnancy
Time Frame: 3 years
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Time to spontaneous pregnancy after breast cancer diagnosis, for women with a desire to become pregnant and trying to get pregnant.
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3 years
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Contraceptive prevalence
Time Frame: 3 years
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Contraceptive use, defined as the percentage of women reporting use of a contraceptive method.
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3 years
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Rate of women considered with risk of unintended pregnancy
Time Frame: 3 years
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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.
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3 years
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Percentage of live births obtained by medically assisted procreation procedures
Time Frame: 3 years
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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.
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3 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne-Sophie HAMY-PETIT, MD, Institut CURIE
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IC 2016-07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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