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

NCT ID: NCT00712452

Last Updated: 2013-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

systemic lupus erythematosus

Group Type OTHER

Biology and ultrasonography after chemotherapy

Intervention Type OTHER

Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)

2

breast cancer

Group Type OTHER

Biology and ultrasonography after chemotherapy

Intervention Type OTHER

Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)

3

Hodgkin disease

Group Type OTHER

Biology and ultrasonography after chemotherapy

Intervention Type OTHER

Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type OTHER

Other Intervention Names

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cyclophosphamide 5FU, épirubicine, cyclephosphamide, taxanes adriamycine, bléomycine, vinblastine, daunorubicine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renato Fanchin, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Locations

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AP-HP Hôpital Antoine Béclère

Clamart, , France

Site Status

Countries

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France

Other Identifiers

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P070707

Identifier Type: -

Identifier Source: org_study_id

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