Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)
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|ClinicalTrials.gov Identifier: NCT02871167|
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : July 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Controlled ovarian hyperstimulation (COH) Procedure: Oocyte/embryo freezing||Not Applicable|
- Information and collection of consent,
- Imaging staging,
- 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)
- 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
- Clinical exam before each cycle of chemotherapy
- AMH, AFC at cycle 6
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: Oocyte/embryo cryopreservation
Procedure: 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.
Procedure: 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).
- 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.
- Quality of embryos: total number of embryos preserved [ Time Frame: at 44-46 hours post intra-cell sperm injection ]
- Type of oocytes [ Time Frame: after oocyte retrieval (35-36 hours after triptorelin injection) ]mature, immature, fractured
- 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
- 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 ]
- Antral Follicular Count (AFC) measurement [ Time Frame: baseline, at month 3, at month 12, at month 24 ]
- 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)
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871167
|Contact: Audrey Maillez, MDfirstname.lastname@example.org|
|Contact: Christine Decanter, MD||+33 3 20 44 68 email@example.com|
|Study Director:||Audrey Maillez, MD||Centre Oscar Lambret|
|Study Director:||Christine Decanter, MD||CHRU of Lille - Hôpital Jeanne de Flandre|