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Future of Spermatogenesis in Men With Sickle Cell Disease Medically Treated (HYDREP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01609192
First received: April 25, 2012
Last updated: August 6, 2013
Last verified: August 2013
  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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: April 2010
Study Completion Date: February 2013
Primary Completion Date: February 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609192

Locations
France
Department of biology of reproduction (TENON Hospital- AP-HP)
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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: August 6, 2013
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
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014