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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC-K14-010 | Other Grant/Funding Number | INCA | |
| 2024-513078-23-00 | EU Trial (CTIS) Number | ||
| 2016-000808-28 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
| National Cancer Institute, France | OTHER_GOV |
| University Hospital, Montpellier | OTHER |
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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.
Medical Oncology:
Reproductive medicine center:
Adjuvant chemotherapy:
During chemotherapy:
After chemotherapy:
physical examination at Month 3 (M3), M6 M9 M12 M18 and M24 and mammography at M9 then annual
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oocyte/embryo cryopreservation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of embryos: total number of embryos preserved | at 44-46 hours post intra-cell sperm injection | |
| Type of oocytes | mature, immature, fractured | after oocyte retrieval (35-36 hours after triptorelin injection) |
| Measure | Description | Time Frame |
|---|---|---|
| Translational research : circulating nucleic acids quantification: cell-free DNA and microRNAs on blood sample | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Audrey Maillez, MD | Centre Oscar Lambret | Study Director |
| Christine Decanter, MD | CHRU of Lille - Hôpital Jeanne de Flandre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jean Verdier | Bondy | 93140 | France | |||
| Centre Aliénor d'Aquitaine, Hôpital Pellegrin |
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| 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). |
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| 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 | 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 |
| Number of Spontaneous or medically assisted pregnancy(ies) | 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 | 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 | 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 |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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