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Impact of an Antioxidant Alimentary Complement on Sperm Data

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ClinicalTrials.gov Identifier: NCT01841034
Recruitment Status : Unknown
Verified February 2013 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
Male infertility is a multifactorial disease process with a number of potential contributive causes. Considering the majority of male infertility cases are due to deficient sperm production of unknown origin, environmental and nutritional factors must be evaluated. The purpose of this study is to evaluate the effects of 6 months antioxidant dietary complement (Conceptio) on sperm parameters (sperm count, motility and DNA fragmentation) in infertile men with oligoasthenozoospermia.

Condition or disease Intervention/treatment
Infertility Drug: Conceptio EA

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a 6 Months Treatment of Conceptio (EA) on Sperm Data in Infertile Men With Oligoasthenozoospermia
Study Start Date : September 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Conceptio
Any patient receipt within the framework of the coverage(care) of an infertility in the pole ORG, whatever is the étiologie and the type of treatment proposing and presenting during at least two spermogrammes an oligospermie and\or an asthénospermie. The necessity of realizing 2 spermogrammes different to determine the pathological character of the values of a spermogramme takes into account the personal variability of the results.
Drug: Conceptio EA
The patients are included during a consultation whether it is with a clinician or a biologist of the Center. It is suggested in routine in the service, to all the patients consulting for a problem of infertility and presenting pathological spermatic data, taking the food complement Conceptio. At the patients wishing to take this complement it will be suggested participating in this study. This complement is usually bought by the patient, within the framework of this study this one will be gracefully supplied. The follow-up of the patient will contain no examination and no anybody visit besides the usually realized follow-up.




Primary Outcome Measures :
  1. Spermatic parameters (numeration and mobility spermatic) [ Time Frame: At the inclusion and 6 months after the inclusion ]
    The spermatic parameters used within the framework of the spermogramme made in routine in the Laboratory of Biology of the Reproduction will be the numeration and the spermatic mobility from the very beginning.


Secondary Outcome Measures :
  1. Rate of fragmentation of the DNA [ Time Frame: At the inclusion and 6 months after the inclusion ]
    We shall consider the rate of fragmentation of the DNA determined according to the method of the TUNEL. This technique allows to estimate the rate of spermatozoides apoptose. It brings to light the fragmentation of the spermatic DNA in the course of process of cellular death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient receipt within the framework of the care of an infertility in the pole ORG, whatever is the étiologie and the type of treatment proposing and presenting during at least two spermogrammes an oligospermie and\or an asthénospermie.
Criteria

Inclusion Criteria:

  • Number of sperm cells < 15M / mL and\or mobility < 40 %.
  • Signature of a form of not opposition to the research.
  • Membership in a social security system.

Exclusion Criteria:

  • Number of sperm cells = 100M / mL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841034


Contacts
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Contact: ISNARD Véronique, PH +3349206403 ext +33492036424 isnard.v@chu-nice.fr
Contact: BENHAMED Mohamed, MD +3349206403 benhamed.m@chu-nice.fr

Locations
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France
CHU de Nice - Hôpital de l'Archet Recruiting
Nice, Alpes-Maritimes, France, 06001
Contact: ISNARD Véronique, PH    +3349206403    isnard.v@chu-nice.fr   
Contact: BENHAMED Mohamed, MD    +3349206403    benhamed.m@chu-nice.fr   
Principal Investigator: ISNARD Véronique, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: ISNARD Véronique, PH CHU de Nice - CECOS- Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01841034     History of Changes
Other Study ID Numbers: 11-PP-13
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: February 2013
Keywords provided by Centre Hospitalier Universitaire de Nice:
Male
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs