Male Infertility Due to Antisperm AntibodySPERMARNCT04591470
Influence of Inguinal Hernia Repair on Sperm Autoimmunity
An observational study of Male Infertility Due to Antisperm Antibody, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Influence of inguinal hernia repair on sperm autoimmunity using MAR test Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Male Infertility Due to Antisperm Antibody
- What is being tested?
- Mar test
- How many people
- 2,415 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- 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.
Who may be able to join
- Patients undergone to correction of inguinal hernia
Who cannot join
- No specific exclusion criteria were set.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Inguinal Hernia Repair on Sperm Autoimmunity Using MAR Test
Influence of inguinal hernia repair on sperm autoimmunity using MAR test
Read the 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
- Being tested
- Mar test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mar testDiagnostic test
Study of antisperm antibodies
| Study group | Role | What they receive |
|---|---|---|
| General population | Not described Receives: Diagnostic Test: Mar test | |
| Pazients undergone inguinal hernia correction | Not described Receives: Diagnostic Test: Mar test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty
Measured: 20 years
Secondary outcomes (1)
Evaluate if there is a modification of seminal parameters among patients undergoing inguinal hernioplasty
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jun 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Male Infertility Due to Antisperm AntibodyStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591470
- Sponsor's protocol ID
- 64/20
- Acronym
- SPERMAR
- Status last verified
- Oct 2020
- First submitted
- 10 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32556769Stula I, Druzijanic N, Sapunar A, Perko Z, Bosnjak 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.
PubMed 24962853Matsuda 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.
PubMed 8558661
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Inguinal Hernia Repair on Sperm Autoimmunity Using MAR Test
- ClinicalTrials.gov ID
- NCT04591470
- Acronym / sponsor ID
- SPERMAR / 64/20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,415 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General population | – | Diagnostic Test: Mar test |
| Pazients undergone inguinal hernia correction | – | Diagnostic Test: Mar test |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patients undergone to correction of inguinal hernia
Key exclusion criteria (1 listed)
- No specific exclusion criteria were set.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mar testStudy of antisperm antibodies | Diagnostic test | General population, Pazients undergone inguinal hernia correction |
Primary outcome
Evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty
Time frame: 20 years
1 secondary outcome
Evaluate if there is a modification of seminal parameters among patients undergoing inguinal hernioplasty
Time frame: 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 32556769Gupta 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.
- Background: PubMed 24962853Stula I, Druzijanic N, Sapunar A, Perko Z, Bosnjak 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.
- Background: PubMed 8558661Matsuda 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility Due to Antisperm Antibody, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591470, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.