Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation
NCT ID: NCT02871167
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
140 participants
INTERVENTIONAL
2016-12-31
2034-11-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Oocyte/embryo cryopreservation
1. Controlled ovarian hyperstimulation (COH)
2. Oocyte/embryo freezing
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.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
38 Years
FEMALE
No
Sponsors
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University Hospital, Lille
OTHER
National Cancer Institute, France
OTHER_GOV
University Hospital, Montpellier
OTHER
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Audrey Maillez, MD
Role: STUDY_DIRECTOR
Centre Oscar Lambret
Christine Decanter, MD
Role: STUDY_DIRECTOR
CHRU of Lille - Hôpital Jeanne de Flandre
Locations
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Hôpital Jean Verdier
Bondy, , France
Centre Aliénor d'Aquitaine, Hôpital Pellegrin
Bordeaux, , France
CHU de Caen
Caen, , France
Centre François Baclesse
Caen, , France
Hôpital Antoine Béclère
Clamart, , France
Centre Georges François LECLERC
Dijon, , France
CHU de Dijon
Dijon, , France
CHU REUNION site SUD
La Réunion, , France
Centre Oscar Lambret
Lille, , France
CHRU Hôpital Jeanne de Flandres
Lille, , France
CHU Limoges
Limoges, , France
CHU Lyon
Lyon, , France
Centre Léon Bérard
Lyon, , France
CHU La Conception
Marseille, , France
Institut Paoli Calmette
Marseille, , France
CHRU Montpellier
Montpellier, , France
ICM - Val d'Aurelle
Montpellier, , France
CHRU de Nancy
Nancy, , France
Institut Curie
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital TENON
Paris, , France
CHU Rouen
Rouen, , France
Centre Henri Becquerel
Rouen, , France
Institut Curie
Saint-Cloud, , France
Hôpital Universitaire de Strasbourg
Strasbourg, , France
Oncopole-CHU Toulouse
Toulouse, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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2016-000808-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PHRC-K14-010
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CHACRY-1501
Identifier Type: -
Identifier Source: org_study_id
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