FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France

NCT03884413 | Completed

• 1 other identifier: IC 2016-07
• Study Type: observational
• Target: 517
• Locations: 1 country
• Sites: 1

Brief Summary

FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

Conditions

Breast Cancer Female

Keywords

breast cancer survivors,; spontaneous fertility rates,; pregnancy,; birth rate,; chemotherapy-induced infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to spontaneous pregnancy

  3 years

• Contraceptive prevalence

  3 years

• Rate of women considered with risk of unintended pregnancy

  3 years

• Percentage of live births obtained by medically assisted procreation procedures

  3 years

Study Arms (2)

Breast cancer survivors

Study of spontaneous fertility outcomes following breast cancer history

Other: questionnaires

Control group

Study of spontaneous fertility outcomes in healthy volonteers population

Other: questionnaires

Interventions

questionnaires OTHER

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

Breast cancer survivors; Control group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with previous diagnosis of breast cancer and time from diagnosis comprised between one and five years

You may qualify if:

• 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) .

You may not qualify if:

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

Sponsors & Collaborators

• Institut Curie: lead
• seintinelles network: collaborator

Study Sites (1)

Seintinelles.Com

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 35525718 RESULT

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anne-Sophie HAMY-PETIT, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: March 21, 2019
• Study Start: March 8, 2018
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2022
• Last Updated: August 11, 2025

Record last verified: 2018-11

Locations

FR (1)