Overview

This trial is active, not recruiting.

Condition male infertility
Treatment blood sample, sperm sample and clinical examens
Sponsor Assistance Publique - Hôpitaux de Paris
Start date July 2013
End date October 2016
Trial size 170 participants
Trial identifier NCT01974947, NI 10033

Summary

Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who conduct their sperm test through their diagnosis of infertility

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Man partner of an infertile couple. Blood sample, sperm sample and clinical examens will be done at the day of the inclusion
blood sample, sperm sample and clinical examens
Blood sample, sperm sample and clinical examens will be done at the day of the inclusion

Primary Outcomes

Measure
Number of spermatozoid and their relation with syndrome metabolic parameters
time frame: Day 0

Secondary Outcomes

Measure
Relationship between spermogram and spermocytogram and other metabolic parameters
time frame: Day 0
Environmental parameters
time frame: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
time frame: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
time frame: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
time frame: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
time frame: Day 0

Eligibility Criteria

Male participants from 18 years up to 45 years old.

Inclusion Criteria: - 18 to 45 years-old man - man consulting for primary or secondary infertility, with or without earlier notion of paternity - patient insured with a social security scheme - patient who have had a prior medical consultation - patient who have done informed and written consent to participate in the research study Exclusion Criteria: - patient with problems understanding French - patient smoking more than two-pack-a-day - patient monitoring for viral risk. - man with an unidiopathic infertility which may be explained by: 1) identifiable factors in direct questioning at the sperm analysis: - exposure to toxic products - infectious disease history - pathological anatomical background 2) factors identified at the etiologic investigation: cytogenetic and genetic

Additional Information

Official title Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man
Principal investigator Rachel Lévy, MD, PhD
Description Assessment of sperm parameters and metabolic syndrome relations in men attending a Reproductive Biomedicine centre for an infertility of their couple. Secondary objectives are to study relationship between sperm parameters and: - adiposity and insulin resistance - inflammation - oxydative stress in blood and semen - hormonal status Innovative parameters will also be assessed to determine the quality of semen (length of fingers, wrist circumference and epigenetics studies)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.