Breast Cancer FemaleFEERICNCT03884413
FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France
An observational study of Breast Cancer Female, run by Institut Curie at 1 site in France.
Trial summary
FErtility, PrEgnancy, contRaceptIon after breast Cancer in France Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- questionnaires
- How many people
- 517 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2018to 8 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with previous diagnosis of breast cancer and time from diagnosis comprised between one and five years
Who may be able to join
- 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) .
Who cannot join
- hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy
- healthy volonteer with history of malignant disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France: the FEERIC Study
FErtility, PrEgnancy, contRaceptIon after breast Cancer in France
Read the 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…).
- Conditions
- Breast Cancer Female
- Being tested
- questionnaires
- Keywords
- breast cancer survivors,, spontaneous fertility rates,, pregnancy,, birth rate,, chemotherapy-induced infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Longitudinal observational study. Collection of health data using self-administered questionnaires online.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivors | Study of spontaneous fertility outcomes following breast cancer history Receives: Other: questionnaires | |
| Control group | Study of spontaneous fertility outcomes in healthy volonteers population Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (4)
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.
Measured: 3 years
Contraceptive prevalence
Contraceptive use, defined as the percentage of women reporting use of a contraceptive method.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start8 Mar 2018
- Primary completion8 Mar 2021
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- seintinelles network
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie HAMY-PETIT, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884413
- Sponsor's protocol ID
- IC 2016-07
- Acronym
- FEERIC
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mangiardi-Veltin M, Sebbag C, Rousset-Jablonski C, Ray-Coquard I, Berkach C, Laot L, Wang Y, Abdennebi I, Labrosse J, Sautter C, Toussaint A, Sablone L, Laas E, Khallouch S, Coussy F, Santulli P, Chapron C, Bobrie A, Jacot W, Sella N, Dumas E, Senechal-Davin C, Espie M, Giacchetti S, Maitrot L, Plu-Bureau G, Coutant C, Guerin J, Asselain B, Fumoleau P, Rodrigues M, Decanter C, Mailliez A, Delrieu L, Lemoine A, Jouannaud C, Houdre D, Reyal F, Hamy AS; Seintinelles Research Network. Pregnancy, fertility concerns and fertility preservation procedures in a national study of French breast cancer survivors. Reprod Biomed Online. 2022 Jun;44(6):1031-1044. doi: 10.1016/j.rbmo.2021.12.019. Epub 2022 Jan 19.
PubMed 35525718
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France: the FEERIC Study
- ClinicalTrials.gov ID
- NCT03884413
- Acronym / sponsor ID
- FEERIC / IC 2016-07
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer survivors,, spontaneous fertility rates,, pregnancy,, birth rate,, chemotherapy-induced infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- seintinelles network
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors | – | Other: questionnairesStudy of spontaneous fertility outcomes following breast cancer history |
| Control group | – | Other: questionnairesStudy of spontaneous fertility outcomes in healthy volonteers population |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with previous diagnosis of breast cancer and time from diagnosis comprised between one and five years
Key inclusion criteria (2 listed)
- 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) .
Key exclusion criteria (2 listed)
- hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy
- healthy volonteer with history of malignant disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesLongitudinal observational study. Collection of health data using self-administered questionnaires online. | Other | Breast cancer survivors, Control group |
Primary outcome
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.
4 secondary outcomes
Time to spontaneous pregnancy
Time frame: 3 years
Contraceptive prevalence
Time frame: 3 years
Rate of women considered with risk of unintended pregnancy
Time frame: 3 years
Percentage of live births obtained by medically assisted procreation procedures
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Results publication: PubMed 35525718Mangiardi-Veltin M, Sebbag C, Rousset-Jablonski C, Ray-Coquard I, Berkach C, Laot L, Wang Y, Abdennebi I, Labrosse J, Sautter C, Toussaint A, Sablone L, Laas E, Khallouch S, Coussy F, Santulli P, Chapron C, Bobrie A, Jacot W, Sella N, Dumas E, Senechal-Davin C, Espie M, Giacchetti S, Maitrot L, Plu-Bureau G, Coutant C, Guerin J, Asselain B, Fumoleau P, Rodrigues M, Decanter C, Mailliez A, Delrieu L, Lemoine A, Jouannaud C, Houdre D, Reyal F, Hamy AS; Seintinelles Research Network. Pregnancy, fertility concerns and fertility preservation procedures in a national study of French breast cancer survivors. Reprod Biomed Online. 2022 Jun;44(6):1031-1044. doi: 10.1016/j.rbmo.2021.12.019. Epub 2022 Jan 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie HAMY-PETIT, MD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous pregnancies between cases and controls (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.