Influence of Inguinal Hernia Repair on Sperm Autoimmunity

Male Infertility Due to Antisperm Antibody Clinical Trial

— SPERMAR  

Official title:

Influence of Inguinal Hernia Repair on Sperm Autoimmunity Using MAR Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591470
• Other study ID #: 64/20
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Influence of inguinal hernia repair on sperm autoimmunity using MAR test

Description:

All infertile male patients, visited between February 2000 and September 2020 and which were tested with MAR (Mixed Autoglobulin Reaction) test, were included in this retrospective study. Sperm quality (number of spermatozoa, motility, vitality and normal forms) were also studied in this patients. The aim of the study is to evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty compared to the general population

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2415
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients undergone to correction of inguinal hernia

Exclusion Criteria:

• No specific exclusion criteria were set.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Hernia, Inguinal
• Infertility
• Infertility, Male
• Male Infertility Due to Antisperm Antibody

Intervention

Diagnostic Test:
• Mar test
Study of antisperm antibodies

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Štula I, Družijanic N, Sapunar A, Perko Z, Bošnjak N, Kraljevic D. Antisperm antibodies and testicular blood flow after inguinal hernia mesh repair. Surg Endosc. 2014 Dec;28(12):3413-20. doi: 10.1007/s00464-014-3614-7. Epub 2014 Jun 25. — View Citation

Gupta S, Krishna A, Jain M, Goyal A, Kumar A, Chaturvedi P, Sagar R, Ramachandran R, Prakash O, Kumar S, Seenu V, Bansal V. A three-arm randomized study to compare sexual functions and fertility indices following open mesh hernioplasty (OMH), laparoscopic totally extra peritoneal (TEP) and transabdominal preperitoneal (TAPP) repair of groin hernia. Surg Endosc. 2020 Jun 15. doi: 10.1007/s00464-020-07697-z. [Epub ahead of print] — View Citation

Matsuda T, Hiura Y, Muguruma K, Okuno H, Horii Y, Yoshida O. Quantitative analysis of testicular histology in patients with vas deferens obstruction caused by childhood inguinal herniorrhaphy: comparison to vasectomized men. J Urol. 1996 Feb;155(2):564-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty		20 years
Secondary	Evaluate if there is a modification of seminal parameters among patients undergoing inguinal hernioplasty		20 years