Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation
CHACRY
4 other identifiers
interventional
140
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Dec 2016
Longer than P75 for not_applicable breast-cancer
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 18, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2034
ExpectedMarch 18, 2026
March 1, 2026
7.5 years
July 28, 2016
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
after oocyte retrieval (35-36 hours after triptorelin injection)
Secondary Outcomes (8)
Quality of embryos: total number of embryos preserved
at 44-46 hours post intra-cell sperm injection
Type of oocytes
after oocyte retrieval (35-36 hours after triptorelin injection)
Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale
24 months
Serum AMH measurement
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
baseline, at month 3, at month 12, at month 24
- +3 more secondary outcomes
Other Outcomes (1)
Translational research : circulating nucleic acids quantification: cell-free DNA and microRNAs on blood sample
an average of 6 months
Study Arms (1)
Oocyte/embryo cryopreservation
EXPERIMENTAL1. Controlled ovarian hyperstimulation (COH) 2. Oocyte/embryo freezing
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- University Hospital, Lillecollaborator
- National Cancer Institute, Francecollaborator
- University Hospital, Montpelliercollaborator
Study Sites (28)
Hôpital Jean Verdier
Bondy, 93140, France
Centre Aliénor d'Aquitaine, Hôpital Pellegrin
Bordeaux, 33076, France
CHU de Caen
Caen, 14033, France
Centre François Baclesse
Caen, 14076, France
Hôpital Antoine Béclère
Clamart, 92140, France
Centre Georges François LECLERC
Dijon, 21079, France
CHU de Dijon
Dijon, 21079, France
CHU REUNION site SUD
La Réunion, 97410, France
Centre Oscar Lambret
Lille, 59020, France
CHRU Hôpital Jeanne de Flandres
Lille, 59037, France
CHU Limoges
Limoges, 87042, France
CHU Lyon
Lyon, 69229, France
Centre Léon Bérard
Lyon, 69373, France
CHU La Conception
Marseille, 13005, France
Institut Paoli Calmette
Marseille, 13273, France
CHRU Montpellier
Montpellier, 34295, France
ICM - Val d'Aurelle
Montpellier, 34298, France
CHRU de Nancy
Nancy, 54000, France
Institut Curie
Paris, 75005, France
Hôpital Cochin
Paris, 75014, France
Hôpital TENON
Paris, 75020, France
CHU Rouen
Rouen, 76031, France
Centre Henri Becquerel
Rouen, 76038, France
Institut Curie
Saint-Cloud, 92210, France
Hôpital Universitaire de Strasbourg
Strasbourg, 67091, France
Oncopole-CHU Toulouse
Toulouse, 31059, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Audrey Maillez, MD
Centre Oscar Lambret
- STUDY DIRECTOR
Christine Decanter, MD
CHRU of Lille - Hôpital Jeanne de Flandre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 18, 2016
Study Start
December 1, 2016
Primary Completion
June 5, 2024
Study Completion (Estimated)
November 1, 2034
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share