NCT01974947

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2016

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.5 years

First QC Date

July 26, 2013

Last Update Submit

November 17, 2025

Conditions

Male Infertility

Keywords

Metabolic syndromeEpigeneticMale infertilitySperm parametersBiomarkers

Outcome Measures

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 .

    Day 0

Secondary Outcomes (6)

  • Relationship between spermogram and spermocytogram and other metabolic parameters

    Day 0

  • Environmental parameters

    Day 0

  • Relationship between spermogram and spermocytogram and other metabolic parameters

    Day 0

  • Relationship between spermogram and spermocytogram and other metabolic parameters

    Day 0

  • Relationship between spermogram and spermocytogram and other metabolic parameters

    Day 0

  • +1 more secondary outcomes

Study Arms (1)

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

Blood sample, sperm sample and clinical examensOTHER

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

Infertile men

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Man consulting for primary or secondary infertility, with or without earlier notion of paternity

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Verdier Hospital

Bondy, 93140, France

Location

Related Publications (7)

  • 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.

    PMID: 23242914BACKGROUND

  • 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.

    PMID: 18929048BACKGROUND

  • 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.

    PMID: 22412113BACKGROUND

  • 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.

    PMID: 22999785BACKGROUND

  • 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.

    PMID: 31115360RESULT

  • 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.

    PMID: 31705791RESULT

  • 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.

    PMID: 35668388DERIVED

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

MeSH Terms

Conditions

Infertility, MaleMetabolic Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Rachel Lévy, MD, PhD

    Tenon Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2013

First Posted

November 4, 2013

Study Start

July 18, 2013

Primary Completion

January 20, 2016

Study Completion

January 20, 2016

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

FR(1)