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NCT Number: NCT02871167

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jean Verdier, Bondy, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled ovarian hyperstimulation (COH)

Procedure

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 freezing

Procedure

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Quality of embryos: total number of embryos preserved

    Time frame: at 44-46 hours post intra-cell sperm injection

  2. Type of oocytes

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

    mature, immature, fractured

  3. 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

  4. 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

  5. Antral Follicular Count (AFC) measurement

    Time frame: baseline, at month 3, at month 12, at month 24

  6. 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)

  7. 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

  8. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CHACRY

Important dates

Study start
2016
Primary completion
2024
Study completion
2034
First posted
Aug 18, 2016
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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