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

NCT00712452 — Not applicable, Terminated, 19 participants, Assistance Publique - Hôpitaux de Paris

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

Registry	NCT00712452, acronym IROCHIM
Status	Terminated - problems of insuffisant recruitment
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none
Enrollment	19 (Actual)
Sponsor	Assistance Publique - Hôpitaux de Paris (Other)
Conditions	Infertility
Interventions	Biology and ultrasonography after chemotherapy (Other)
Dates	start 2008-06-01, primary completion 2009-06-01, completion 2009-06-01, first posted 2008-07-10, last updated 2013-05-14
Locations	1 site in France

-Summary

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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
1	Other	Other: Biology and ultrasonography after chemotherapy	systemic lupus erythematosus
2	Other	Other: Biology and ultrasonography after chemotherapy	breast cancer
3	Other	Other: Biology and ultrasonography after chemotherapy	Hodgkin disease

Biology and ultrasonography after chemotherapy (Other), also known as cyclophosphamide: 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), also known as 5FU, épirubicine, cyclephosphamide, taxanes: 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), also known as adriamycine, bléomycine, vinblastine, daunorubicine: Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)

+Outcome measures

Primary outcomes

AMH level and antral follicle count [one year after the chemotherapy treatment]

Secondary outcomes

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]

+Eligibility

Sex: Female, ages: 18 Years to 35 Years

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

+Locations (1)

Facility	City	Country	Status
AP-HP Hôpital Antoine Béclère	Clamart	France

+Investigators

Renato Fanchin, MD, Study director, Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère