Influence of Inguinal Hernia Repair on Sperm Autoimmunity | NCT04591470

Studies
Influence of Inguinal Hernia Repair on Sperm Autoimmunity

NCT04591470

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Nov 6, 2020Actual

Enrollment

2,415Actual

Phase

Not provided

Conditions

Male Infertility Due to Antisperm Antibody

Interventions

Mar test

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Oct 1, 2020Actual

Completion Date

Oct 1, 2020Actual

First Submitted Date

Oct 10, 2020

First Submission Date that Met QC Criteria

Oct 10, 2020

First Posted Date

Oct 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2020

Last Update Posted Date

Nov 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Influence of inguinal hernia repair on sperm autoimmunity using MAR test

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,415Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General population			Diagnostic Test: Mar test
Pazients undergone inguinal hernia correction			Diagnostic Test: Mar test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mar test	Diagnostic Test	Study of antisperm antibodies	General population Pazients undergone inguinal hernia correction

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergone to correction of inguinal hernia

Exclusion Criteria:

No specific exclusion criteria were set.

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Clinico Humanitas		Rozzano	Milano	20089	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32556769	Background	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. 2021 Jun;35(6):3077-3084. doi: 10.1007/s00464-020-07697-z. Epub 2020 Jun 15.
24962853