Infertility
Conditions
Keywords
fertility, chemotherapy
Brief 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.
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.
Interventions
OTHERBiology 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)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AMH level and antral follicle count | one year after the chemotherapy treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed