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CompletedNCT01974947MetaspermeUpdated Nov 20, 2025

Metabolic Syndrome and Male Infertility

An observational study in Male Infertility, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

Read the 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)
02

Conditions studied

  • Male Infertility

Keywords

  • Metabolic syndrome
  • Epigenetic
  • Male infertility
  • Sperm parameters
  • Biomarkers
03

In context

Infertility, Male

264 studies on the registry are indexed under Infertility, Male; 61 are open to participants now.

This study's enrollment of 170 is close to the median of 176 across 86 observational studies indexed under Infertility, Male.

Browse Infertility, Male studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherBlood sample, sperm sample and clinical examens

    Blood sample, sperm sample and clinical examens will be done at the day of the inclusion

06

What researchers measure

Primary outcomes

  1. Number of spermatozoid and their relation with syndrome metabolic parameters

    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 .

    Time frame: Day 0

Secondary outcomes

  1. Relationship between spermogram and spermocytogram and other metabolic parameters

    Relationship between other spermogram/spermocytogram and metabolic markers (biomarkers and anthropometric adiposity and insulin resistance)

    Time frame: Day 0

  2. Environmental parameters

    Evaluation of environmental parameters (physical activity, tobacco consumption, quality of life) by classical questionnaire

    Time frame: Day 0

  3. Relationship between spermogram and spermocytogram and other metabolic parameters

    Relationship between other spermogram/spermocytogram and markers of inflammation

    Time frame: Day 0

  4. Relationship between spermogram and spermocytogram and other metabolic parameters

    Relationship between other spermogram/spermocytogram and markers of oxidative stress (plasma, seminal genetic polymorphisms involved in oxidative stress, genetic analyzes of sperm)

    Time frame: Day 0

  5. Relationship between spermogram and spermocytogram and other metabolic parameters

    Relationship between other spermogram/spermocytogram and hormonal markers

    Time frame: Day 0

  6. Relationship between spermogram and spermocytogram and other metabolic parameters

    Relationship between other spermogram/spermocytogram and innovative settings (studies epigenetic finger length and width of the wrist)

    Time frame: Day 0

07

Study locations

1 site
  • Jean Verdier Hospital
    Bondy, 93140, France
08

References and documents

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, 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. PubMed 23242914 ↗
  • 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. PubMed 18929048 ↗
  • 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. PubMed 22412113 ↗
  • 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. PubMed 22999785 ↗
  • Bongrani A, Elfassy Y, Brun JS, Rame C, Mellouk N, Fellahi S, Bastard JP, Levy R, Vasseur C, Froment P, Dupont J. Expression of adipokines in seminal fluid of men of normal weight. Asian J Androl. 2019 Sep-Oct;21(5):528-530. doi: 10.4103/aja.aja_25_19. No abstract available. PubMed 31115360 ↗
  • Elfassy Y, Bongrani A, Levy P, Foissac F, Fellahi S, Faure C, McAvoy C, Capeau J, Dupont J, Feve B, Levy R, Bastard JP; Metasperme group. Relationships between metabolic status, seminal adipokines, and reproductive functions in men from infertile couples. Eur J Endocrinol. 2020 Jan;182(1):67-77. doi: 10.1530/EJE-19-0615. PubMed 31705791 ↗
  • 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. PubMed 35668388 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01974947
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Nov 4, 2013
Start date
Jul 18, 2013
Primary completion
Jan 20, 2016
Completion
Jan 20, 2016
Last update
Nov 20, 2025

Study contacts

Rachel Lévy, MD, PhD
principal investigator · Tenon Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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