Future of Spermatogenesis in Men With Sickle Cell Disease Medically Treated

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The project's background: Sickle cell disease is, at present in France, the most frequent genetic illness. Recent progress in its treatment, in particular the use of hydroxyurea, has considerably modified the prognosis of this disease. Many more patients now reach reproductive age and do consider fathering. Exceptional studies have reported the potential impact of this medical treatment on the sperm parameters and fertility of male patients. In a retrospective analysis, the investigators found that the observed alterations of semen parameters due to sickle cell disease seem to be exacerbated by hydroxyurea treatment.

The study hypothesis: A large prospective study is essential to assess the potential adverse impact of the medical treatment of sickle cell disease on spermatogenesis and consider the advisability of proposing sperm cryopreservation before this treatment is started.

Primary purpose of the protocol: evaluate the impact of a treatment by hydroxyurea (20-30 mg/kg/day), 6 months after its beginning, in 34 men with sickle cell disease (18-60 years old). The main trial criterion will be the average difference of the concentration of spermatozoa s (millions/ml) in the ejaculate, before and after 6 months of medical treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

• Men from 18 to 60 years old

• Patients diagnosed with sickle-cell anemia homozygote or S beta thal

• Patients for whom a treatment by hydroxyurea is prescribed for the first time.

• Patients having signed the informed consent

• Patients with social security

Exclusion Criteria:

• Patients already subjected to a treatment potentially sterilizing

• Patients under supervision or guardianship

• Patients that must begin or stop(arrest) a transfusional program between the beginning of the hydroxyurea and the spermogram in 6 months of treatment.

• Rate of ferritin > 2500 µg/l