Impact of an Antioxidant Alimentary Complement on Sperm Data

Evaluation of a 6 Months Treatment of Conceptio (EA) on Sperm Data in Infertile Men With Oligoasthenozoospermia

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Conceptio EA

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06001
      • CHU de Nice - Hôpital de l'Archet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of fragmentation of the DNA	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.	At the inclusion and 6 months after the inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: ISNARD Véronique, PH, CHU de Nice - CECOS- Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2011
• Primary Completion (Actual): August 30, 2014
• Study Completion (Actual): June 18, 2015

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimated): April 26, 2013

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Male
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 11-PP-13