Metabolic Syndrome and Male Infertility (Metasperme)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment
Male Infertility	Other: Blood sample, sperm sample and clinical examens

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 .

Secondary Outcome Measures :

1. 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)
2. Environmental parameters [ Time Frame: Day 0 ]
   Evaluation of environmental parameters (physical activity, tobacco consumption, quality of life) by classical questionnaire
3. Relationship between spermogram and spermocytogram and other metabolic parameters [ Time Frame: Day 0 ]
   Relationship between other spermogram/spermocytogram and markers of inflammation
4. 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)
5. Relationship between spermogram and spermocytogram and other metabolic parameters [ Time Frame: Day 0 ]
   Relationship between other spermogram/spermocytogram and hormonal markers
6. 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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes 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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Jean Verdier Hospital
Bondy, France, 93140

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Rachel Lévy, MD, PhD	Tenon Hospital

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Sermondade N, Faure C, Fezeu L, Shayeb AG, Bonde JP, Jensen TK, Van Wely M, Cao J, Martini AC, Eskandar M, Chavarro JE, Koloszar S, Twigt JM, Ramlau-Hansen CH, Borges E Jr, Lotti F, Steegers-Theunissen RP, Zorn B, Polotsky AJ, La Vignera S, Eskenazi B, Tremellen K, Magnusdottir EV, Fejes I, Hercberg S, Lévy R, Czernichow S. BMI in relation to sperm count: an updated systematic review and collaborative meta-analysis. Hum Reprod Update. 2013 May-Jun;19(3):221-31. doi: 10.1093/humupd/dms050. Epub 2012 Dec 12. Review.

Hammoud AO, Gibson M, Peterson CM, Meikle AW, Carrell DT. Impact of male obesity on infertility: a critical review of the current literature. Fertil Steril. 2008 Oct;90(4):897-904. doi: 10.1016/j.fertnstert.2008.08.026. Review.

Sermondade N, Faure C, Fezeu L, Lévy R, Czernichow S; Obesity-Fertility Collaborative Group. Obesity and increased risk for oligozoospermia and azoospermia. Arch Intern Med. 2012 Mar 12;172(5):440-442. doi: 10.1001/archinternmed.2011.1382. Review.

Michalakis K, Mintziori G, Kaprara A, Tarlatzis BC, Goulis DG. The complex interaction between obesity, metabolic syndrome and reproductive axis: a narrative review. Metabolism. 2013 Apr;62(4):457-78. doi: 10.1016/j.metabol.2012.08.012. Epub 2012 Sep 20. Review.

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
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