Metabolic Syndrome and Male Infertility

Completed

• Conditions: Male Infertility
• Interventions: Other: Blood sample, sperm sample and clinical examens

• 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

Arm && Interventions

Group	Intervention	Description
Infertile men	Blood sample, sperm sample and clinical examens	Man partner of an infertile couple. Blood sample, sperm sample and clinical examens will be done at the day of the inclusion

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