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


N/A
18 Years
35 Years
Not Enrolling
Female
Infertility

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

AMH level and antral follicle count

Outcome Time Frame:

one year after the chemotherapy treatment

Safety Issue:

Yes

Principal Investigator

Renato Fanchin, MD

Investigator Role:

Study Director

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Authority:

France: Ministry of Health

Study ID:

P070707

NCT ID:

NCT00712452

Start Date:

June 2008

Completion Date:

June 2009

Related Keywords:

  • Infertility
  • fertility
  • chemotherapy
  • Infertility

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