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

This study has been terminated.
(problems of insuffisant recruitment)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00712452
First received: July 2, 2008
Last updated: May 13, 2013
Last verified: May 2013

July 2, 2008
May 13, 2013
June 2008
June 2009   (final data collection date for primary outcome measure)
AMH level and antral follicle count [ Time Frame: one year after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00712452 on ClinicalTrials.gov Archive Site
  • AMH level and antral follicle count at each visit [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
  • Hormonal status (Estradiol, LH, FSH and progesterone levels) [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
  • Menstrual cyclicity [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
  • pregnancy [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
  • infertility treatment if required [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Infertility
  • 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 Name: cyclophosphamide
  • 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 Name: 5FU, épirubicine, cyclephosphamide, taxanes
  • 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 Name: adriamycine, bléomycine, vinblastine, daunorubicine
  • 1
    systemic lupus erythematosus
    Intervention: Other: Biology and ultrasonography after chemotherapy
  • 2
    breast cancer
    Intervention: Other: Biology and ultrasonography after chemotherapy
  • 3
    Hodgkin disease
    Intervention: Other: Biology and ultrasonography after chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00712452
P070707
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Director: Renato Fanchin, MD Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Assistance Publique - Hôpitaux de Paris
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP