Influence of Inguinal Hernia Repair on Sperm Autoimmunity (SPERMAR)

November 4, 2020 updated by: Istituto Clinico Humanitas

Influence of Inguinal Hernia Repair on Sperm Autoimmunity Using MAR Test

Influence of inguinal hernia repair on sperm autoimmunity using MAR test

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

2415

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

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas

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 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

We collected data from all patients who had performed at least one MAR test and a basal spermiogram and who had performed an andrological visit at the Humanitas Clinical Institute in Rozzano (Milan) between February 2000 to September 2020.

Description

Inclusion Criteria:

  • Patients undergone to correction of inguinal hernia

Exclusion Criteria:

  • No specific exclusion criteria were set.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General population
Diagnostic test: Mar test
Study of antisperm antibodies
Pazients undergone inguinal hernia correction
Diagnostic test: Mar test
Study of antisperm antibodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty
Time Frame: 20 years
20 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate if there is a modification of seminal parameters among patients undergoing inguinal hernioplasty
Time Frame: 20 years
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

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

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)

June 1, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

October 10, 2020

First Submitted That Met QC Criteria

October 10, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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