Metabolic Syndrome and Male Infertility

Completed

• Conditions: Male Infertility

• Registration Number: NCT01974947
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed 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)

Study Timeline

• Study Start: 2013-07-18
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-03
• Primary Completion: 2016-01-20
• Study Completion: 2016-01-20
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of spermatozoid and their relation with syndrome metabolic parameters	Day 0	We will measure the parameters of metabolic syndrome (triglycerides, HDL and LDL cholesterol, systolic and diastolic blood pressure, fasting glucose) and correlate them with the number of spermatozoid .

Secondary Outcome Measures

Name	Time	Method
Environmental parameters	Day 0	Evaluation of environmental parameters (physical activity, tobacco consumption, quality of life) by classical questionnaire
Relationship between spermogram and spermocytogram and other metabolic parameters	Day 0	Relationship between other spermogram/spermocytogram and innovative settings (studies epigenetic finger length and width of the wrist)

Trial Locations

Locations (1)

Jean Verdier Hospital; 🇫🇷 Bondy, France