- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01974947
Metabolic Syndrome and Male Infertility (Metasperme)
November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris
Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man
Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who conduct their sperm test through their diagnosis of infertility
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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)
Study Type
Observational
Enrollment (Actual)
170
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bondy, France, 93140
- Jean Verdier Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 will be done at the day of the inclusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of spermatozoid and their relation with syndrome metabolic parameters
Time Frame: Day 0
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship between spermogram and spermocytogram and other metabolic parameters
Time Frame: Day 0
|
Relationship between other spermogram/spermocytogram and metabolic markers (biomarkers and anthropometric adiposity and insulin resistance)
|
Day 0
|
|
Environmental parameters
Time Frame: Day 0
|
Evaluation of environmental parameters (physical activity, tobacco consumption, quality of life) by classical questionnaire
|
Day 0
|
|
Relationship between spermogram and spermocytogram and other metabolic parameters
Time Frame: Day 0
|
Relationship between other spermogram/spermocytogram and markers of inflammation
|
Day 0
|
|
Relationship between spermogram and spermocytogram and other metabolic parameters
Time Frame: Day 0
|
Relationship between other spermogram/spermocytogram and markers of oxidative stress (plasma, seminal genetic polymorphisms involved in oxidative stress, genetic analyzes of sperm)
|
Day 0
|
|
Relationship between spermogram and spermocytogram and other metabolic parameters
Time Frame: Day 0
|
Relationship between other spermogram/spermocytogram and hormonal markers
|
Day 0
|
|
Relationship between spermogram and spermocytogram and other metabolic parameters
Time Frame: Day 0
|
Relationship between other spermogram/spermocytogram and innovative settings (studies epigenetic finger length and width of the wrist)
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rachel Lévy, MD, PhD, Tenon Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2013
Primary Completion (Actual)
January 20, 2016
Study Completion (Actual)
January 20, 2016
Study Registration Dates
First Submitted
July 26, 2013
First Submitted That Met QC Criteria
November 1, 2013
First Posted (Estimated)
November 4, 2013
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Male
- Male Urogenital Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Insulin Resistance
- Hyperinsulinism
- Infertility
- Nutritional and Metabolic Diseases
- Metabolic Syndrome
- Infertility, Male
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- NI 10033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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