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
  Purpose

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
Infertility
Other: Biology and ultrasonography after chemotherapy
Other: Biology and ultrasonography after chemotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • AMH level and antral follicle count [ Time Frame: one year after the chemotherapy treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
systemic lupus erythematosus
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
2
breast cancer
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
3
Hodgkin disease
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712452

Locations
France
AP-HP Hôpital Antoine Béclère
Clamart, France, 92141
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Renato Fanchin, MD Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00712452     History of Changes
Other Study ID Numbers: P070707
Study First Received: July 2, 2008
Last Updated: May 13, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
fertility
chemotherapy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on April 16, 2014