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AzTrials

Breast CancerCHACRYNCT02871167

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

A study testing Oocyte/embryo freezing in people with Breast Cancer, run by Centre Oscar Lambret at 28 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 38 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Oocyte/embryo freezing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
28 sitesFrance
Study dates
Dec 2016to Nov 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • Hôpital Jean Verdier

    Bondy, 93140

  • Centre Aliénor d'Aquitaine, Hôpital Pellegrin

    Bordeaux, 33076

  • CHU de Caen

    Caen, 14033

  • Centre François Baclesse

    Caen, 14076

  • Hôpital Antoine Béclère

    Clamart, 92140

  • Centre Georges François LECLERC

    Dijon, 21079

  • CHU de Dijon

    Dijon, 21079

  • CHU REUNION site SUD

    La Réunion, 97410

  • Centre Oscar Lambret

    Lille, 59020

  • CHRU Hôpital Jeanne de Flandres

    Lille, 59037

  • CHU Limoges

    Limoges, 87042

  • CHU Lyon

    Lyon, 69229

  • Centre Léon Bérard

    Lyon, 69373

  • CHU La Conception

    Marseille, 13005

  • Institut Paoli Calmette

    Marseille, 13273

  • CHRU Montpellier

    Montpellier, 34295

  • ICM - Val d'Aurelle

    Montpellier, 34298

  • CHRU de Nancy

    Nancy, 54000

  • Institut Curie

    Paris, 75005

  • Hôpital Cochin

    Paris, 75014

  • Hôpital TENON

    Paris, 75020

  • CHU Rouen

    Rouen, 76031

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut Curie

    Saint-Cloud, 92210

  • Hôpital Universitaire de Strasbourg

    Strasbourg, 67091

  • Oncopole-CHU Toulouse

    Toulouse, 31059

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: 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.

Read the 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
Conditions
Breast Cancer
Being tested
Controlled ovarian hyperstimulation (COH), Oocyte/embryo freezing
Keywords
oocyte/embryo cryopreservation
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Controlled ovarian hyperstimulation (COH)Procedure or surgery

    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.

  • Oocyte/embryo freezingProcedure or surgery

    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).

Study groups in NCT02871167
Study groupRoleWhat they receive
Oocyte/embryo cryopreservationExperimental1. Controlled ovarian hyperstimulation (COH) 2. Oocyte/embryo freezing
Receives: Procedure: Controlled ovarian hyperstimulation (COH); Procedure: Oocyte/embryo freezing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of oocytes: total number of oocytes preserved

    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.

    Measured: after oocyte retrieval (35-36 hours after triptorelin injection)

Secondary outcomes (8)

  1. Quality of embryos: total number of embryos preserved

    Measured: at 44-46 hours post intra-cell sperm injection

  2. Type of oocytes

    mature, immature, fractured

    Measured: after oocyte retrieval (35-36 hours after triptorelin injection)

  3. Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale

    Toxicities will be tabulated with frequencies and percentages by type of adverse events and by grade

    Measured: 24 months

  4. Serum AMH measurement

    Measured: 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

  5. Antral Follicular Count (AFC) measurement

    Measured: baseline, at month 3, at month 12, at month 24

  6. Number of Spontaneous or medically assisted pregnancy(ies)

    To measure the degree of project completion of subsequent pregnancy(ies)

    Measured: up to 10 years after the end of the study or at 43 years old

  7. Rate of patients wishing for re-utilization of their frozen gametes

    To assess the number of patients wishing for re-utilization of their frozen gametes

    Measured: up to 10 years after the end of the study or at 43 years old

  8. Disease-free survival

    defined as the interval between inclusion and the first occurrence of local, regional or distant relapse, estimated using the Kaplan-Meier method

    Measured: through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion5 Jun 2024
  4. Study completionNov 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871167
Sponsor's protocol ID
CHACRY-1501
Other IDs
PHRC-K14-010, 2024-513078-23-00, 2016-000808-28, 2016
Acronym
CHACRY
Status last verified
Mar 2026
First submitted
28 Jul 2016
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oocyte/embryo freezing in people with Breast Cancer, run by Centre Oscar Lambret at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of oocytes: total number of oocytes preserved (time frame: after oocyte retrieval (35-36 hours after triptorelin injection)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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