SPERMAR: Influence of Inguinal Hernia Repair on Sperm Autoimmunity
Sponsor
Istituto Clinico Humanitas (Other)
Overall Status
Completed
CT.gov ID
NCT04591470
Collaborator
(none)
2,415
1
4
602.5
Study Details
Study Description
Brief Summary
Influence of inguinal hernia repair on sperm autoimmunity using MAR test
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational
Actual Enrollment
:
2415 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Influence of Inguinal Hernia Repair on Sperm Autoimmunity Using MAR Test
Actual Study Start Date
:
Jun 1, 2020
Actual Primary Completion Date
:
Oct 1, 2020
Actual Study Completion Date
:
Oct 1, 2020
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty [20 years]
Secondary Outcome Measures
- Evaluate if there is a modification of seminal parameters among patients undergoing inguinal hernioplasty [20 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
Male
Inclusion Criteria:
- Patients undergone to correction of inguinal hernia
Exclusion Criteria:
- No specific exclusion criteria were set.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Clinico Humanitas | Rozzano | Milano | Italy | 20089 |
Sponsors and Collaborators
- Istituto Clinico Humanitas
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Štula I, Družijanić N, Sapunar A, Perko Z, Bošnjak N, Kraljević 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.
Responsible Party:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT04591470
Other Study ID Numbers:
- 64/20
First Posted:
Oct 19, 2020
Last Update Posted:
Nov 6, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: