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NCT01114464 Clinical Trial

Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer

Ovarian Reserve Clinical Trial

— Resova  

Official title:
Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01114464
Other study ID # BRD/09/06-J
Secondary ID
Status Terminated
Phase N/A
First received April 28, 2010
Last updated August 5, 2016
Start date January 2010
Est. completion date April 2014

Study information
Verified date August 2016
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations and after during follow-up (24 months). This strategy offers 2 main advantages : no modification of the traditional care of patients (treatment, organisation, follow up …) and use of a non invasive marker (serum). The final objective is to give precise information to patients on their future fertility after remission.

Recruitment information / eligibility
Status Terminated
Enrollment 250
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria:

- female 18-39 years

- suffering from breast cancer

- treated with adjuvant or neoadjuvant chemotherapy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Institut Bergonié Bordeaux
France Centre François BACLESSE Caen
France Centre Jean Perrin Clermont-Ferrand
France CRLC de Bourgogne Georges François Leclerc Dijon
France Centre Oscar Lambret Lille
France Centre de Lutte Contre le Cancer Léon Bérard Lyon
France Centre Val d'Aurelle - Paul Lamarque Montpellier
France Institut Curie Paris
France Institut Jean Godinot Reims
France Centre Eugène Marquis Rennes
France Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau Saint Herblain

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients Serum anti-Müllerian hormone concentration will be measured at each chemotherapy administration and 24 months follow-up after chemotherapy completion 24 months No
See also
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Completed NCT03621683 - Antioxidants vs. Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve N/A
Completed NCT04058678 - Effects of Telomerase Reactivation With Danazol in Ovarian Function. N/A
Recruiting NCT05743218 - Clinical Efficacy of Acupuncture on the Liver Meridian in Women With Diminished Ovarian Reserve N/A
Recruiting NCT04487925 - Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders Phase 4
Active, not recruiting NCT00928044 - The Impact of Gynecological Surgery on Ovarian Function in Women of Reproductive Age: Postoperative Changes of Serum Anti-Müllerian Hormone (AMH) N/A