Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)

February 13, 2023 updated by: Centre Oscar Lambret

Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93140
        • Not yet recruiting
        • Hôpital Jean Verdier
      • Bordeaux, France, 33076
        • Recruiting
        • Centre Aliénor d'Aquitaine, Hôpital Pellegrin
      • Caen, France, 14033
        • Recruiting
        • CHU de Caen
      • Caen, France, 14076
        • Recruiting
        • Centre Francois Baclesse
      • Clamart, France, 92140
        • Recruiting
        • Hôpital Antoine Béclère
      • Dijon, France, 21079
        • Recruiting
        • CHU de Dijon
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges François Leclerc
      • La Réunion, France, 97410
        • Recruiting
        • CHU Réunion Site Sud
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
      • Lille, France, 59037
        • Recruiting
        • CHRU Hôpital Jeanne de Flandres
      • Limoges, France, 87042
        • Recruiting
        • Chu Limoges
      • Lyon, France, 69373
        • Recruiting
        • Centre Leon Berard
      • Lyon, France, 69229
        • Recruiting
        • CHU LYON
      • Marseille, France, 13005
        • Recruiting
        • CHU la Conception
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli Calmette
      • Montpellier, France, 34298
        • Recruiting
        • ICM - Val d'Aurelle
      • Montpellier, France, 34295
        • Recruiting
        • CHRU Montpellier
      • Nancy, France, 54000
        • Recruiting
        • CHRU de Nancy
      • Paris, France, 75005
        • Recruiting
        • Institut Curie
      • Paris, France, 75014
        • Recruiting
        • Hopital Cochin
      • Paris, France, 75020
        • Recruiting
        • Hopital Tenon
      • Rouen, France, 76038
        • Recruiting
        • Centre Henri Becquerel
      • Rouen, France, 76031
        • Recruiting
        • CHU Rouen
      • Saint-Cloud, France, 92210
        • Recruiting
        • Institut Curie
      • Strasbourg, France, 67091
        • Recruiting
        • Hôpital Universitaire de Strasbourg
      • Toulouse, France, 31059
        • Recruiting
        • Oncopole-CHU Toulouse
      • Vandoeuvre les nancy, France, 54519
        • Recruiting
        • Institut de Cancérologie de Lorraine
      • Villejuif, France, 94805
        • Not yet recruiting
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oocyte/embryo cryopreservation
  1. Controlled ovarian hyperstimulation (COH)
  2. Oocyte/embryo freezing
Procedure: Controlled ovarian hyperstimulation (COH)

After information and consent, patients are addressed to a reproductive medicine center.

The COH will be performed according to a standardized protocol between surgery and the start of adjuvant chemotherapy. Follicular growth will be achieved with an antagonist protocol and by using high dose recombinant FSH (r-FSH). The triggering of the final follicular and oocyte maturation will be obtained by a GnRH (Gonadotropin Releasing Hormone) agonist injection in order to minimize the risk of ovarian hyper-stimulation.

Procedure: Oocyte/embryo freezing
Egg or embryo freezing will be performed according to a standardized protocol: slow-freezing process for embryo; vitrification technique for oocytes. Cryopreserved oocytes and embryos will be stored in the biological bank of each reproductive medicine center (min. 10 years).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of oocytes: total number of oocytes preserved
Time Frame: after oocyte retrieval (35-36 hours after triptorelin injection)
The distribution of the total number of oocytes preserved will be summarized by the mean (standard error) and median (range) and presented with a 95% confidence interval.
after oocyte retrieval (35-36 hours after triptorelin injection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of embryos: total number of embryos preserved
Time Frame: at 44-46 hours post intra-cell sperm injection
at 44-46 hours post intra-cell sperm injection
Type of oocytes
Time Frame: after oocyte retrieval (35-36 hours after triptorelin injection)
mature, immature, fractured
after oocyte retrieval (35-36 hours after triptorelin injection)
Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale
Time Frame: 24 months
Toxicities will be tabulated with frequencies and percentages by type of adverse events and by grade
24 months
Serum AMH measurement
Time Frame: baseline, at the end of the first sequence of chemotherapy, at the last injection of treatment, at Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
baseline, at the end of the first sequence of chemotherapy, at the last injection of treatment, at Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Antral Follicular Count (AFC) measurement
Time Frame: baseline, at month 3, at month 12, at month 24
baseline, at month 3, at month 12, at month 24
Number of Spontaneous or medically assisted pregnancy(ies)
Time Frame: up to 10 years after the end of the study or at 43 years old
To measure the degree of project completion of subsequent pregnancy(ies)
up to 10 years after the end of the study or at 43 years old
Rate of patients wishing for re-utilization of their frozen gametes
Time Frame: up to 10 years after the end of the study or at 43 years old
To assess the number of patients wishing for re-utilization of their frozen gametes
up to 10 years after the end of the study or at 43 years old
Disease-free survival
Time Frame: through study completion, an average of 5 years
defined as the interval between inclusion and the first occurrence of local, regional or distant relapse, estimated using the Kaplan-Meier method
through study completion, an average of 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Translational research : circulating nucleic acids quantification: cell-free DNA and microRNAs on blood sample
Time Frame: an average of 6 months
before 1st cycle of adjuvant chemotherapy, during the adjuvant chemotherapy (end of first sequence), at the end of adjuvant chemotherapy
an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

University Hospital, Montpellier
National Cancer Institute, France
University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (ESTIMATE)

August 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHACRY-1501
  • 2016-000808-28 (EUDRACT_NUMBER)
  • PHRC-K14-010 (OTHER_GRANT: INCA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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