Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve (IROCHIM)

May 13, 2013 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve.

The objective is to evaluate the influence of chemotherapy, either for auto-immune disease, either for carcinologic disease, on clinical and biological markers of ovarian reserve, for young patients, with normal reproductive functions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study will enrol patients between 18 and 35 years, treated with neoadjuvant or adjuvant chemotherapy for systemic lupus erythematosus (Group 1), breast cancer (Group 2) or Hodgkin disease (Group 3)to evaluate the clinical and biological markers of ovarian reserve. The follow-up will last 24 months for each patients with a visit before treatment, and at 3 months, 6 months, one year and two years after treatment.

During this period, we will collect pre and post treatment clinical data,and biological data and ultrasonographic data such as antral follicle count which is a marker of ovarian follicle reserve.These data were not observed in current practice.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92141
        • AP-HP Hôpital Antoine Beclere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women volunteers treated by chemotherapy,
  • ≥ 18 and ≤ 35 years old
  • Regular menstrual cyclicity, between 25 and 35 days
  • Social security affiliation
  • Signed informed consent

Exclusion Criteria:

  • Women < 18 and > 35 years old
  • Pregnancy
  • Emergent treatment necessity
  • No social security affiliation
  • Virgin patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
systemic lupus erythematosus
Other: Biology and ultrasonography after chemotherapy
Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)
Other Names:
  • adriamycine, bléomycine, vinblastine, daunorubicine
Other: 2
breast cancer
Other: Biology and ultrasonography after chemotherapy
Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)
Other Names:
  • adriamycine, bléomycine, vinblastine, daunorubicine
Other: 3
Hodgkin disease
Other: Biology and ultrasonography after chemotherapy
Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)
Other Names:
  • adriamycine, bléomycine, vinblastine, daunorubicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AMH level and antral follicle count
Time Frame: one year after the chemotherapy treatment
one year after the chemotherapy treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
AMH level and antral follicle count at each visit
Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment
3 months, 6 months, and two years after the chemotherapy treatment
Hormonal status (Estradiol, LH, FSH and progesterone levels)
Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment
3 months, 6 months, and two years after the chemotherapy treatment
Menstrual cyclicity
Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment
3 months, 6 months, and two years after the chemotherapy treatment
pregnancy
Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment
3 months, 6 months, and two years after the chemotherapy treatment
infertility treatment if required
Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment
3 months, 6 months, and two years after the chemotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Renato Fanchin, MD, Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimate)

July 10, 2008

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P070707

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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