Ovarian ReserveResovaNCT01114464
Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer
An observational study of Ovarian Reserve, run by Nantes University Hospital at 11 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Ovarian Reserve
- How many people
- 250 participants
- Where
- 11 sitesFrance
- Study dates
- Jan 2010to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Young women with breast cancer
Who may be able to join
- female 18-39 years
- suffering from breast cancer
- treated with adjuvant or neoadjuvant chemotherapy
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Institut Bergonié
Bordeaux, 33076
Centre François BACLESSE
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
CRLC de Bourgogne Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59000
Centre de Lutte Contre le Cancer Léon Bérard
Lyon, 69373
Centre Val d'Aurelle - Paul Lamarque
Montpellier, 34098
Institut Curie
Paris, 75005
Institut Jean Godinot
Reims, 51056
Centre Eugène Marquis
Rennes, 35042
Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau
Saint-Herblain, 44805
About this study
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.
- Conditions
- Ovarian Reserve
- Keywords
- Breast cancer, Ovarian reserve, Anti-Mullerian Hormone (AMH), Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| young women with breast cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: end of normal study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Barrière, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114464
- Sponsor's protocol ID
- BRD/09/06-J
- Acronym
- Resova
- Status last verified
- Aug 2016
- First submitted
- 28 Apr 2010
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Loubersac S, Chaillot M, Reignier A, Lefebvre T, Dezellus A, Colombel A, Barriere P, Masson D, Freour T. Serum androgen dynamics in young women aged 18-40 treated with chemotherapy for breast cancer: an observational, multicentric, prospective study in France. Hum Fertil (Camb). 2024 Dec;27(1):2350758. doi: 10.1080/14647273.2024.2350758. Epub 2024 Jul 3.
PubMed 38957151
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01114464
- Acronym / sponsor ID
- Resova / BRD/09/06-J
- Conditions
- Ovarian Reserve
- Keywords
- Breast cancer, Ovarian reserve, Anti-Mullerian Hormone (AMH), Chemotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: end of normal study
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| young women with breast cancer | – | – |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young women with breast cancer
Key inclusion criteria (3 listed)
- female 18-39 years
- suffering from breast cancer
- treated with adjuvant or neoadjuvant chemotherapy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients
Time frame: 24 months
Serum anti-Müllerian hormone concentration will be measured at each chemotherapy administration and 24 months follow-up after chemotherapy completion
Results and safety
The study was stopped early (reason given: end of normal study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Derived from this study: PubMed 38957151Loubersac S, Chaillot M, Reignier A, Lefebvre T, Dezellus A, Colombel A, Barriere P, Masson D, Freour T. Serum androgen dynamics in young women aged 18-40 treated with chemotherapy for breast cancer: an observational, multicentric, prospective study in France. Hum Fertil (Camb). 2024 Dec;27(1):2350758. doi: 10.1080/14647273.2024.2350758. Epub 2024 Jul 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Barrière, MD principal investigator
Nantes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Reserve, run by Nantes University Hospital at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: end of normal study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01114464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.