Impact of an Antioxidant Alimentary Complement on Sperm Data

Completed

• Conditions: Infertility
• Interventions: Drug: Conceptio EA

• Registration Number: NCT01841034
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-30
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-26
• Primary Completion: 2014-08-30
• Study Completion: 2015-06-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conceptio	Conceptio EA	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.

Primary Outcome Measures

Name	Time	Method
Spermatic parameters (numeration and mobility spermatic)	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

Name	Time	Method
Rate of fragmentation of the DNA	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.

Trial Locations

Locations (1)

CHU de Nice - Hôpital de l'Archet; 🇫🇷 Nice, Alpes-Maritimes, France