Trial record 6 of 33 for:    Open Studies | "Infertility, Male"

Metabolic Syndrome and Male Infertility (Metasperme)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01974947
First received: July 26, 2013
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Male Infertility
Other: Blood sample, sperm sample and clinical examens

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Number of spermatozoid and their relation with syndrome metabolic parameters [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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:
  • Relationship between spermogram and spermocytogram and other metabolic parameters [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Relationship between other spermogram/spermocytogram and metabolic markers (biomarkers and anthropometric adiposity and insulin resistance)

  • Environmental parameters [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Relationship between other spermogram/spermocytogram and markers of inflammation

  • Relationship between spermogram and spermocytogram and other metabolic parameters [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Relationship between other spermogram/spermocytogram and hormonal markers

  • Relationship between spermogram and spermocytogram and other metabolic parameters [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Relationship between other spermogram/spermocytogram and innovative settings (studies epigenetic finger length and width of the wrist)


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 520
Study Start Date: July 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infertile men
Man partner of an infertile couple. Blood sample, sperm sample and clinical examens will be done at the day of the inclusion
Other: Blood sample, sperm sample and clinical examens
Blood sample, sperm sample and clinical examens will be done at the day of the inclusion

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)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Man consulting for primary or secondary infertility, with or without earlier notion of paternity

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974947

Contacts
Contact: Rachel Lévy, MD, PhD +331 48 02 68 80 rachel.levy@jvr.aphp.fr
Contact: Laurence Lecomte, PhD +331 58 41 35 45 laurence.lecomte@cch.aphp.fr

Locations
France
Jean Verdier Hospital Recruiting
Bondy, France, 93140
Contact: Rachel Lévy, MD, PhD    +331 48 02 68 80    rachel.levy@jvr.aphp.fr   
Principal Investigator: Rachel Lévy, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Rachel Lévy, MD, PhD Jean Verdier Hospital
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01974947     History of Changes
Other Study ID Numbers: NI 10033
Study First Received: July 26, 2013
Last Updated: August 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Metabolic syndrome
Epigenetic
Male infertility
Sperm parameters
Biomarkers

Additional relevant MeSH terms:
Infertility, Male
Syndrome
Infertility
Metabolic Syndrome X
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014