Male InfertilityMetaspermeNCT01974947
Metabolic Syndrome and Male Infertility
An observational study of Male Infertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who conduct their sperm test through their diagnosis of infertility Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- Blood sample, sperm sample and clinical examens
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2013to 20 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Study population: Man consulting for primary or secondary infertility, with or without earlier notion of paternity
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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)
- Conditions
- Male Infertility
- Being tested
- Blood sample, sperm sample and clinical examens
- Keywords
- Metabolic syndrome, Epigenetic, Male infertility, Sperm parameters, Biomarkers
- Medical subject headings
- Infertility, Male, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample, sperm sample and clinical examensOther
Blood sample, sperm sample and clinical examens will be done at the day of the inclusion
| Study group | Role | What they receive |
|---|---|---|
| Infertile men | Man partner of an infertile couple. Blood sample, sperm sample and clinical examens will be done at the day of the inclusion Receives: Other: Blood sample, sperm sample and clinical examens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Day 0
Secondary outcomes (6)
Relationship between spermogram and spermocytogram and other metabolic parameters
Relationship between other spermogram/spermocytogram and metabolic markers (biomarkers and anthropometric adiposity and insulin resistance)
Measured: Day 0
Environmental parameters
Evaluation of environmental parameters (physical activity, tobacco consumption, quality of life) by classical questionnaire
Measured: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
Relationship between other spermogram/spermocytogram and markers of inflammation
Measured: Day 0
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)
Measured: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
Relationship between other spermogram/spermocytogram and hormonal markers
Measured: Day 0
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)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study start18 Jul 2013
- Primary completion20 Jan 2016
- Study completion20 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Rachel Lévy, MD, PhD, Principal investigator, Tenon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974947
- Sponsor's protocol ID
- NI 10033
- Acronym
- Metasperme
- Status last verified
- Oct 2025
- First submitted
- 26 Jul 2013
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
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 23242914Hammoud 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 18929048Sermondade 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 22412113Michalakis 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 22999785Bongrani 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 31115360Elfassy 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 31705791Saget 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man
- ClinicalTrials.gov ID
- NCT01974947
- Acronym / sponsor ID
- Metasperme / NI 10033
- Conditions
- Male Infertility
- Keywords
- Metabolic syndrome, Epigenetic, Male infertility, Sperm parameters, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 18 Jul 2013 (actual)
- Primary completion
- 20 Jan 2016 (actual)
- Study completion
- 20 Jan 2016 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile men | – | Other: Blood sample, sperm sample and clinical examensMan partner of an infertile couple. Blood sample, sperm sample and clinical examens will be done at the day of the inclusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Man consulting for primary or secondary infertility, with or without earlier notion of paternity
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
- exposure to toxic products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample, sperm sample and clinical examensBlood sample, sperm sample and clinical examens will be done at the day of the inclusion | Other | Infertile men |
Primary outcome
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 .
6 secondary outcomes
Relationship between spermogram and spermocytogram and other metabolic parameters
Time frame: Day 0
Environmental parameters
Time frame: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
Time frame: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
Time frame: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
Time frame: Day 0
Relationship between spermogram and spermocytogram and other metabolic parameters
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 23242914Sermondade 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.
- Background: PubMed 18929048Hammoud 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.
- Background: PubMed 22412113Sermondade 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.
- Background: PubMed 22999785Michalakis 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.
- Results publication: PubMed 31115360Bongrani 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.
- Results publication: PubMed 31705791Elfassy 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.
- Derived from this study: PubMed 35668388Saget 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Lévy, MD, PhD principal investigator
Tenon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of spermatozoid and their relation with syndrome metabolic parameters (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974947, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.