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
|
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Condition or disease | Intervention/treatment |
---|---|
Male Infertility | Other: Blood sample, sperm sample and clinical examens |
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 Type : | Observational |
Actual Enrollment : | 170 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man |
Actual Study Start Date : | July 18, 2013 |
Actual Primary Completion Date : | January 20, 2016 |
Actual Study Completion Date : | January 20, 2016 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
- 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 .
- 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)
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

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974947
France | |
Jean Verdier Hospital | |
Bondy, France, 93140 |
Principal Investigator: | Rachel Lévy, MD, PhD | Tenon Hospital |
Publications:
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01974947 History of Changes |
Other Study ID Numbers: |
NI 10033 |
First Posted: | November 4, 2013 Key Record Dates |
Last Update Posted: | March 19, 2018 |
Last Verified: | March 2018 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Metabolic syndrome Epigenetic Male infertility Sperm parameters Biomarkers |
Additional relevant MeSH terms:
Metabolic Syndrome X Infertility Infertility, Male Insulin Resistance Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Genital Diseases, Male Genital Diseases, Female |