Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation

Last updated: February 11, 2025
Sponsor: Centre Oscar Lambret
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Breast Cancer

Infertility

Cancer

Treatment

Controlled ovarian hyperstimulation (COH)

Oocyte/embryo freezing

Clinical Study ID

NCT02871167
CHACRY-1501
PHRC-K14-010
2016-000808-28
  • Ages 18-38
  • Female

Study Summary

The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women with histologically proven breast cancer

  • Aged 18 to 38 years old

  • Planned adjuvant chemotherapy

  • No prior chemotherapy

  • Affiliated to a public health insurance program

  • Informed consent signed by the patient

Exclusion

Exclusion Criteria:

  • Metastatic breast cancer

  • Planned neo-adjuvant chemotherapy

  • Hysterectomy

  • Exclusive adjuvant hormonotherapy

  • Positive serology for syphilis, hepatitis B or C, or VIH

  • Contraindication related to use of r-FSH

  • Pregnant or breastfeeding patients

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Controlled ovarian hyperstimulation (COH)
Phase:
Study Start date:
December 01, 2016
Estimated Completion Date:
November 30, 2034

Study Description

Medical Oncology:

  • Information and collection of consent,

  • Imaging staging,

  • Inclusion

  • Physical examination

  • Contraception advise given

Reproductive medicine center:

  • Ovarian reserve assessment: serum anti-mullerian hormone (AMH) measurement and antral follicle count (AFC) by ultrasound.

  • Serology syphilis, hepatitis B and C, HIV (human immunodeficiency virus). In case of embryo cryopreservation, same serology determination for the men.

  • Infertility risk and fertility preservation techniques information.

  • In case of agreement, this technique will be done during the time-interval between surgery and chemotherapy

  • Fertility preservation (COH stimulation, triggering and oocyte retrieval)

Adjuvant chemotherapy:

  • The chemotherapy regimen is 3 FEC (fluorouracil epirubicin cyclophosphamide) 100 followed by standard chemotherapy (according to local practice) +/- Trastuzumab. Adjuvant chemotherapy may only begin after the oocyte retrieval.

  • Usual adjuvant chemotherapy is not changed

During chemotherapy:

  • Clinical exam before each cycle of chemotherapy

  • AMH, AFC at cycle 6

After chemotherapy:

  • Usual patient monitoring in expert center :

physical examination at Month 3 (M3), M6 M9 M12 M18 and M24 and mammography at M9 then annual

  • AMH at Month 3 (M3), M6 M9 M12 M18 and M24

  • AFC at Month 12 (M12) and M24

Connect with a study center

  • Hôpital Jean Verdier

    Bondy, 93140
    France

    Site Not Available

  • Centre Aliénor d'Aquitaine, Hôpital Pellegrin

    Bordeaux, 33076
    France

    Site Not Available

  • CHU de Caen

    Caen, 14033
    France

    Site Not Available

  • Centre François Baclesse

    Caen, 14076
    France

    Site Not Available

  • Hôpital Antoine Béclère

    Clamart, 92140
    France

    Site Not Available

  • CHU de Dijon

    Dijon, 21079
    France

    Site Not Available

  • Centre Georges François LECLERC

    Dijon, 21079
    France

    Site Not Available

  • CHU REUNION site SUD

    La Réunion, 97410
    France

    Site Not Available

  • CHRU Hôpital Jeanne de Flandres

    Lille, 59037
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, 59020
    France

    Site Not Available

  • CHU Limoges

    Limoges, 87042
    France

    Site Not Available

  • CHU Lyon

    Lyon, 69229
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69373
    France

    Site Not Available

  • CHU La Conception

    Marseille, 13005
    France

    Site Not Available

  • Institut Paoli Calmette

    Marseille, 13273
    France

    Site Not Available

  • CHRU Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • ICM - Val d'Aurelle

    Montpellier, 34298
    France

    Site Not Available

  • CHRU de Nancy

    Nancy, 54000
    France

    Site Not Available

  • Hôpital Cochin

    Paris, 75014
    France

    Site Not Available

  • Hôpital TENON

    Paris, 75020
    France

    Site Not Available

  • Institut Curie

    Paris, 75005
    France

    Site Not Available

  • CHU Rouen

    Rouen, 76031
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen, 76038
    France

    Site Not Available

  • Institut Curie

    Saint-Cloud, 92210
    France

    Site Not Available

  • Hôpital Universitaire de Strasbourg

    Strasbourg, 67091
    France

    Site Not Available

  • Oncopole-CHU Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Vandoeuvre les nancy, 54519
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

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