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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01114464

Acronym

Resova

Enrollment

250

Registered

2010-05-03

Start date

2010-01-31

Completion date

2014-04-30

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Reserve

Keywords

Breast cancer, Ovarian reserve, Anti-Mullerian Hormone (AMH), Chemotherapy

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

Healthy volunteers

Inclusion criteria

* female 18-39 years * suffering from breast cancer * treated with adjuvant or neoadjuvant chemotherapy

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients	24 months	Serum anti-Müllerian hormone concentration will be measured at each chemotherapy administration and 24 months follow-up after chemotherapy completion

Countries

France

Outcome results