Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2028-01-31

Brief Summary

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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.

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Detailed Description

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The patients will have a follow-up once a year during ten years beginning at the end of their chemotherapy.

They will have a consultation in oncology consisting of:

* a clinical exam,
* a collection and follow-up of oncological data
* a collection of ongoing cancer treatments

and a consultation in gynecology consisting of:

* a pelvic ultrasound scan (for AFC: Antral Follicle Count)
* a biological test (FSH, LH, E2, AMH)
* a collection of gynecological data, contraception and reproductive medicine

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study Process

Consultation, Biological Test, Pelvic Ultrasound

Group Type EXPERIMENTAL

Consultation

Intervention Type PROCEDURE

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

Biological Test

Intervention Type BIOLOGICAL

Blood test:

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

Pelvic Ultrasound

Intervention Type PROCEDURE

Antral Follicles Count

Interventions

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Consultation

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

Intervention Type PROCEDURE

Biological Test

Blood test:

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

Intervention Type BIOLOGICAL

Pelvic Ultrasound

Antral Follicles Count

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No