Infertility Clinical Trial
Official title:
Evaluation of a 6 Months Treatment of Conceptio (EA) on Sperm Data in Infertile Men With Oligoasthenozoospermia
NCT number | NCT01841034 |
Other study ID # | 11-PP-13 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 30, 2011 |
Est. completion date | June 18, 2015 |
Verified date | March 2024 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice - Hôpital de l'Archet | Nice | Alpes-Maritimes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
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 |
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