Future of Spermatogenesis in Men With Sickle Cell Disease Medically Treated (HYDREP)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Drepanocytic Men Treated by Hydroxyurea for the First Time |
Drug: Hydrea® (hydroxyurea ) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Future of Spermatogenesis in Men With Sickle Cell Disease Medically Treated. |
- The primary outcomes will be the average difference of the concentration of spermatozoa in the ejaculate measured before treatment and after 6 months of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- the average difference of the sperm DNA fragmentation in the ejaculate measured before treatment and after 6 months of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- the average difference of the mobility of spermatozoa in the ejaculate measured before treatment and after 6 months of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- the average difference of the vitality of spermatozoa in the ejaculate measured before treatment and after 6 months of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- the average difference of the morphology of spermatozoa in the ejaculate measured before treatment and after 6 months of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 34 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: hydroxyurea |
Drug: Hydrea® (hydroxyurea )
treatment by hydroxyurea (20-30 mg/kg/day) for 6 months
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Jacqueline Mandelbaum, Dr | 00 33 1 56 01 78 01/02 | jacqueline.mandelbaum@tnn.aphp.fr |
| France | |
| Department of biology of reproduction (TENON Hospital- AP-HP) | Recruiting |
| Paris, France, 75020 | |
| Contact: Jacqueline Mandelbaum, Dr 00 33 1 56 01 78 01/02 jacqueline.mandelbaum@tnn.aphp.fr | |
| Principal Investigator: Jacqueline Mandelbaum, Dr | |
| Principal Investigator: | Jacqueline Mandelbaum, Dr | Assistance Publique |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01609192 History of Changes |
| Other Study ID Numbers: | P 081227, AOM 09154 |
| Study First Received: | April 25, 2012 |
| Last Updated: | May 29, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: French Data Protection Authority |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
sickle-cell anemia spermatogenesis hydroxyurea |
Additional relevant MeSH terms:
|
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Hydroxyurea |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antisickling Agents Hematologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013