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

Study Overview
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Other: Biology and ultrasonography after chemotherapy
* Other: Biology and ultrasonography after chemotherapy
* Other: Biology and ultrasonography after chemotherapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>systemic lupus erythematosus | Other: Biology and ultrasonography after chemotherapy<br>* Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)<br>* Other names: cyclophosphamide;|
| Other: 2<br>breast cancer | Other: Biology and ultrasonography after chemotherapy<br>* Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)<br>* Other names: 5FU, épirubicine, cyclephosphamide, taxanes;|
| Other: 3<br>Hodgkin disease | Other: Biology and ultrasonography after chemotherapy<br>* Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)<br>* Other names: adriamycine, bléomycine, vinblastine, daunorubicine;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fertility, chemotherapy