Metabolic Syndrome and Male Infertility

NCT ID: NCT01974947

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-18

Study Completion Date

2016-01-20

Brief Summary

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

Detailed Description

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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)

Conditions

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Male Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infertile men

Man partner of an infertile couple. Blood sample, sperm sample and clinical examens will be done at the day of the inclusion

Blood sample, sperm sample and clinical examens

Intervention Type OTHER

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

Interventions

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Blood sample, sperm sample and clinical examens

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Lévy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tenon Hospital

Locations

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Jean Verdier Hospital

Bondy, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 18929048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22412113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22999785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23242914 (View on PubMed)

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.

Reference Type RESULT
PMID: 31115360 (View on PubMed)

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.

Reference Type RESULT
PMID: 31705791 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35668388 (View on PubMed)

Other Identifiers

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NI 10033

Identifier Type: -

Identifier Source: org_study_id

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