Clinical trial NCT01974947: Metabolic Syndrome and Male Infertility
Official title: Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Infertility
Keywords: Metabolic syndrome
Epigenetic
Male infertility
Sperm parameters
Biomarkers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 170
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Man consulting for primary or secondary infertility, with or without earlier notion of paternity

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

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 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

Primary outcomes:
measure: Number of spermatozoid and their relation with syndrome metabolic parameters
timeFrame: Day 0
Secondary outcomes:
measure: Relationship between spermogram and spermocytogram and other metabolic parameters
timeFrame: Day 0
measure: Environmental parameters
timeFrame: Day 0
measure: Relationship between spermogram and spermocytogram and other metabolic parameters
timeFrame: Day 0
measure: Relationship between spermogram and spermocytogram and other metabolic parameters
timeFrame: Day 0
measure: Relationship between spermogram and spermocytogram and other metabolic parameters
timeFrame: Day 0
measure: Relationship between spermogram and spermocytogram and other metabolic parameters
timeFrame: Day 0
Other outcomes:
Locations:
city: Bondy
country: France
facility: Jean Verdier Hospital
Study officials:
affiliation: Tenon Hospital
name: Rachel Lévy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Levy 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.
citation: 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.
citation: Sermondade N, Faure C, Fezeu L, Levy 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.
citation: 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.
citation: Saget S, Kappeler L, Grandjean V, Leneuve P, Berthaut I, Faure C, Czernichow S, Racine C, Levy R, Dupont C; Metasperme Collaboratif group. Association between metabolic disorders and seminal plasma miRNA levels: a pilot study. Basic Clin Androl. 2022 Jun 7;32(1):9. doi: 10.1186/s12610-022-00159-7.