Metabolic Syndrome and Male Infertility - Full Text View

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:

Genetics Home Reference related topics: CATSPER1-related nonsyndromic male infertility sensorineural deafness and male infertility Y chromosome infertility

MedlinePlus related topics: Infertility Male Infertility Metabolic Syndrome

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

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:

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):440-2. 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
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 Infertility, Male Metabolic Syndrome X Genital Diseases, Female Genital Diseases, Male	Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases

ClinicalTrials.gov processed this record on March 03, 2015

Metabolic Syndrome and Male Infertility (Metasperme)