Metabolic Syndrome and Male Infertility

Male Infertility Clinical Trial

— Metasperme  

Official title:

Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974947
• Other study ID #: NI 10033
• Status: Completed
• First received: July 26, 2013
• Last updated: March 16, 2018
• Start date: July 18, 2013
• Est. completion date: January 20, 2016

Study information

• Verified date: March 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 20, 2016
• Est. primary completion date: January 20, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility
• Metabolic Syndrome X

Intervention

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

Locations

Country	Name	City	State
France	Jean Verdier Hospital	Bondy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

Sermondade N, Faure C, Fezeu L, Lévy 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. Review. — View Citation

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, Lévy 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relationship between spermogram and spermocytogram and other metabolic parameters	Relationship between other spermogram/spermocytogram and metabolic markers (biomarkers and anthropometric adiposity and insulin resistance)	Day 0
Secondary	Environmental parameters	Evaluation of environmental parameters (physical activity, tobacco consumption, quality of life) by classical questionnaire	Day 0
Secondary	Relationship between spermogram and spermocytogram and other metabolic parameters	Relationship between other spermogram/spermocytogram and markers of inflammation	Day 0
Secondary	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)	Day 0
Secondary	Relationship between spermogram and spermocytogram and other metabolic parameters	Relationship between other spermogram/spermocytogram and hormonal markers	Day 0
Secondary	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)	Day 0