Impact of an Antioxidant Alimentary Complement on Sperm Data

NCT01841034 | Completed

• 1 other identifier: 11-PP-13
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Male

Outcome Measures

Primary Outcomes (1)

• Spermatic parameters (numeration and mobility spermatic)

  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.

  At the inclusion and 6 months after the inclusion

Secondary Outcomes (1)

• Rate of fragmentation of the DNA

  At the inclusion and 6 months after the inclusion

Study Arms (1)

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

Interventions

Conceptio EA DRUG

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.

Conceptio

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Number of sperm cells = 100M / mL.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-Maritimes, 06001, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• ISNARD Véronique, PH

  CHU de Nice - CECOS- Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: April 26, 2013
• Study Start: May 30, 2011
• Primary Completion: August 30, 2014
• Study Completion: June 18, 2015
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

FR (1)