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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00712452 |
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.
Condition | Intervention |
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Infertility |
Other: Biology and ultrasonography after chemotherapy Other: Biology and ultrasonography after chemotherapy |
Study Type: | Interventional |
Study Design: | Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve. |
Estimated Enrollment: | 126 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
systemic lupus erythematosus
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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)
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2
breast cancer
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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)
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3
Hodgkin disease
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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)
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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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Claire Basille, MD | +33 (0)1-4537 3622 | claire.basille@abc.aphp.fr |
France | |
AP-HP Hôpital Antoine Béclère | Recruiting |
Clamart, France, 92141 | |
Contact: Michael Grynberg, MD +33 (0)-1 4537 3622 michael.grynberg@abc.aphp.fr | |
Principal Investigator: Renato Fanchin, MD |
Study Director: | Renato Fanchin, MD | Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère |
Responsible Party: | Clinical Research Delegation ( Yannick VACHER ) |
Study ID Numbers: | P070707 |
Study First Received: | July 2, 2008 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00712452 History of Changes |
Health Authority: | France: Ministry of Health |
fertility chemotherapy |
Infertility Immunologic Factors Progesterone Estradiol valerate Vinblastine Cyclophosphamide Estradiol 17 beta-cypionate Genital Diseases, Male Immunosuppressive Agents Doxorubicin |
Estradiol Genital Diseases, Female Fluorouracil Estradiol 3-benzoate Antineoplastic Agents, Alkylating Antirheumatic Agents Polyestradiol phosphate Alkylating Agents Taxane |
Infertility Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Genital Diseases, Male Immunosuppressive Agents |
Pharmacologic Actions Genital Diseases, Female Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |