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Metabolic Syndrome and Male Infertility (Metasperme)

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ClinicalTrials.gov Identifier: NCT01974947
Recruitment Status : Completed
First Posted : November 4, 2013
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

July 26, 2013
November 4, 2013
March 19, 2018
July 18, 2013
January 20, 2016   (Final data collection date for primary outcome measure)
Number of spermatozoid and their relation with syndrome metabolic parameters [ Time Frame: 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 .
Same as current
Complete list of historical versions of study NCT01974947 on ClinicalTrials.gov Archive Site
  • Relationship between spermogram and spermocytogram and other metabolic parameters [ Time Frame: Day 0 ]
    Relationship between other spermogram/spermocytogram and metabolic markers (biomarkers and anthropometric adiposity and insulin resistance)
  • Environmental parameters [ Time Frame: 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 [ Time Frame: Day 0 ]
    Relationship between other spermogram/spermocytogram and markers of inflammation
  • Relationship between spermogram and spermocytogram and other metabolic parameters [ Time Frame: Day 0 ]
    Relationship between other spermogram/spermocytogram and markers of oxidative stress (plasma, seminal genetic polymorphisms involved in oxidative stress, genetic analyzes of sperm)
  • Relationship between spermogram and spermocytogram and other metabolic parameters [ Time Frame: Day 0 ]
    Relationship between other spermogram/spermocytogram and hormonal markers
  • Relationship between spermogram and spermocytogram and other metabolic parameters [ Time Frame: Day 0 ]
    Relationship between other spermogram/spermocytogram and innovative settings (studies epigenetic finger length and width of the wrist)
Same as current
Not Provided
Not Provided
 
Metabolic Syndrome and Male Infertility
Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man
Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who conduct their sperm test through their diagnosis of infertility

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)
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and sperm samples will be collected from all patients BLOOD :Whole blood was collected on dry, heparin or EDTA tubes. After several soft turnings, tubes were centrifuged at 1900g for 10min.Then plasma, serum, buffy coat or red blood cells were taken in microtubes and frozen at -80°C.

SPERM: After liquefaction, total sperm was centrifuged at 600g for 10min. Seminal plasma was collected directly on microtubes and stored at -80°C. After trypsinisation, spermatozoa were fixed in Carnoy solution and stored at -20°C.

DNA was separated from buffy coat using DNA extract kit

Non-Probability Sample
Man consulting for primary or secondary infertility, with or without earlier notion of paternity
Male Infertility
Other: Blood sample, sperm sample and clinical examens
Blood sample, sperm sample and clinical examens will be done at the day of the inclusion
Infertile men
Man partner of an infertile couple. Blood sample, sperm sample and clinical examens will be done at the day of the inclusion
Intervention: Other: Blood sample, sperm sample and clinical examens

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
520
January 20, 2016
January 20, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01974947
NI 10033
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Rachel Lévy, MD, PhD Tenon Hospital
Assistance Publique - Hôpitaux de Paris
March 2018