Impact of an Antioxidant Alimentary Complement on Sperm Data

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841034
• Other study ID #: 11-PP-13
• Status: Completed
• Start date: May 30, 2011
• Est. completion date: June 18, 2015

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 18, 2015
• Est. primary completion date: August 30, 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nice - Hôpital de l'Archet	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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