NCT03795246

Brief Summary

Interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. This study follows a previous one called NCT 01614704.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
20mo left

Started Apr 2018

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Apr 2018Jan 2028

Study Start

First participant enrolled

April 12, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

9.7 years

First QC Date

December 31, 2018

Last Update Submit

March 16, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Assessment of fertility in terms of cumulative incidence of long-term pregnancy

    for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation

    10 years after chemotherapy

Secondary Outcomes (7)

  • Assessment of fertility in terms of cumulative incidence of births

    10 years after chemotherapy

  • Assessment of fertility - number of pegnancies spontaneous versus assisted

    10 years after chemotherapy

  • Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately

    10 years after chemotherapy

  • Assessment of the number of patient willing to re-exploit their frozen gametes

    10 years after chemotherapy

  • Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate

    10 years after chemotherapy

  • +2 more secondary outcomes

Study Arms (1)

Study Process

EXPERIMENTAL

Consultation, Biological Test, Pelvic Ultrasound

Procedure: ConsultationBiological: Biological TestProcedure: Pelvic Ultrasound

Interventions

ConsultationPROCEDURE

Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine

Study Process
Biological TestBIOLOGICAL

Blood test: * FSH, LH, E2 and AMH * 4 tubes of 7 mL

Study Process
Pelvic UltrasoundPROCEDURE

Antral Follicles Count

Study Process

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients included in the study CT 01614704
  • Informed and written consent
  • Affiliated to the National Social Security System

You may not qualify if:

  • Impossibility to submit at the study procedures due to geographic, social or mental reasons
  • Patient deprived of their liberty or under guardianship or tutorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Audrey MAILLIEZ, MD

    Centre Oscar Lambret

    STUDY DIRECTOR

  • Christine DECANTER, MD

    Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2018

First Posted

January 7, 2019

Study Start

April 12, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

FR(1)