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problems of insuffisant recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | systemic lupus erythematosus |
|
| 2 | Other | breast cancer |
|
| 3 | Other | Hodgkin disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biology and ultrasonography after chemotherapy | Other | Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice) |
| Measure | Description | Time Frame |
|---|---|---|
| AMH level and antral follicle count | one year after the chemotherapy treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renato Fanchin, MD | Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP Hôpital Antoine Béclère | Clamart | 92141 | France |
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|
| Biology and ultrasonography after chemotherapy | Other | Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice) |
|
|
| Biology and ultrasonography after chemotherapy | Other | Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice) |
|
|
| 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 |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001685 | Biological Factors |
| D003520 | Cyclophosphamide |
| D005472 | Fluorouracil |
| D043823 | Taxoids |
| D004317 | Doxorubicin |
| D014747 | Vinblastine |
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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