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

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Infertility

Treatments: Other: Biology and ultrasonography after chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00712452

P070707

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

19 participants in 3 patient groups

1

Other group

Description:

systemic lupus erythematosus

Treatment:

Other: Biology and ultrasonography after chemotherapy

Other: Biology and ultrasonography after chemotherapy

Other: Biology and ultrasonography after chemotherapy

2

Other group

Description:

breast cancer

Treatment:

Other: Biology and ultrasonography after chemotherapy

Other: Biology and ultrasonography after chemotherapy

Other: Biology and ultrasonography after chemotherapy

3

Other group

Description:

Hodgkin disease

Treatment:

Other: Biology and ultrasonography after chemotherapy

Other: Biology and ultrasonography after chemotherapy

Other: Biology and ultrasonography after chemotherapy