Male InfertilityNCT05302856
CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
A study testing Blood test (CMV IGG, Anti sperm antibody, Testosterone levels) in people with Male Infertility, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
To assess whether the presence of Cytomegalovirus (CMV) Immunoglobulin G (IGG) antibodies in semen is a reliable predictor of male subfertility or infertility. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Mar 2022to Mar 2023
- Phase
- Interventional
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All male patients addressing the infertility unit in Hadassah Mt Scopus for IVF procedure
Who cannot join
- Refusal to participate
- Male partner utilizing pre cycle frozen sperm sample
- Donor sperm cycles
- Surgically retrieved sperm
Trial locations and contacts
1 site in 1 country.
Anat Hershko klement, MD contact
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
Chana Adler Lazarovits, MD
About this study
To assess whether the presence of Cytomegalovirus (CMV) Immunoglobulin G (IGG) antibodies in semen is a reliable predictor of male subfertility or infertility.
Read the detailed description
Prospective cohort study performed in the artificial reproductive technology (ART) unit.
The study will evaluate semen and serum samples from the following groups:
- Presumably fertile male patients going through ART treatment (for preimplantation genetic testing (PGT) or female indications).
- Subfertile/infertile male patients with abnormal semen analysis.
- Male patients suffering from unexplained infertility. All samples will be collected on the day of ovum retrieval procedure, and the semen samples will be evaluated only after completing the fertilization process. The samples will be tested for CMV IGG antibodies and testosterone levels in semen and serum. In addition, anti-sperm antibodies will be measured in the serum. The ratio between CMV IGG antibodies in semen and serum will be calculated, and will be compared with presence of hormone profile, semen analysis parameters and ART parameters.
- Conditions
- Male Infertility
- Being tested
- Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)
- Keywords
- sperm, blood testis barrier, cmv antibody, unexplained infertility
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)Diagnostic test
Peripheric blood extraction
| Study group | Role | What they receive |
|---|---|---|
| Presumably fertile male patients going through ART treatment | Experimental | Not described Receives: Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels) |
| Subfertile/infertile male patients with abnormal semen analysis | Experimental | Not described Receives: Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels) |
| Male patients suffering from unexplained infertility | Experimental | Not described Receives: Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV antibody ratio serum/semen
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start2 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chana Adler, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302856
- Sponsor's protocol ID
- IGGSEMEN-HMO-CTIL
- Status last verified
- Aug 2022
- First submitted
- 28 Feb 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haverfield JT, Meachem SJ, Nicholls PK, Rainczuk KE, Simpson ER, Stanton PG. Differential permeability of the blood-testis barrier during reinitiation of spermatogenesis in adult male rats. Endocrinology. 2014 Mar;155(3):1131-44. doi: 10.1210/en.2013-1878. Epub 2013 Jan 1.
PubMed 24424039Stanton PG. Regulation of the blood-testis barrier. Semin Cell Dev Biol. 2016 Nov;59:166-173. doi: 10.1016/j.semcdb.2016.06.018. Epub 2016 Jun 25.
PubMed 27353840
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
- ClinicalTrials.gov ID
- NCT05302856
- Acronym / sponsor ID
- IGGSEMEN-HMO-CTIL
- Conditions
- Male Infertility
- Keywords
- sperm, blood testis barrier, cmv antibody, unexplained infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 31 Mar 2022 (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.
To assess whether the presence of Cytomegalovirus (CMV) Immunoglobulin G (IGG) antibodies in semen is a reliable predictor of male subfertility or infertility.
Detailed description
Prospective cohort study performed in the artificial reproductive technology (ART) unit.
The study will evaluate semen and serum samples from the following groups:
- Presumably fertile male patients going through ART treatment (for preimplantation genetic testing (PGT) or female indications).
- Subfertile/infertile male patients with abnormal semen analysis.
- Male patients suffering from unexplained infertility. All samples will be collected on the day of ovum retrieval procedure, and the semen samples will be evaluated only after completing the fertilization process. The samples will be tested for CMV IGG antibodies and testosterone levels in semen and serum. In addition, anti-sperm antibodies will be measured in the serum. The ratio between CMV IGG antibodies in semen and serum will be calculated, and will be compared with presence of hormone profile, semen analysis parameters and ART parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Presumably fertile male patients going through ART treatment | Experimental | Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels) |
| Subfertile/infertile male patients with abnormal semen analysis | Experimental | Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels) |
| Male patients suffering from unexplained infertility | Experimental | Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All male patients addressing the infertility unit in Hadassah Mt Scopus for IVF procedure
Key exclusion criteria (4 listed)
- Refusal to participate
- Male partner utilizing pre cycle frozen sperm sample
- Donor sperm cycles
- Surgically retrieved sperm
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 |
|---|---|---|
| Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)Peripheric blood extraction | Diagnostic test | Male patients suffering from unexplained infertility, Presumably fertile male patients going through ART treatment, Subfertile/infertile male patients with abnormal semen analysis |
Primary outcome
CMV antibody ratio serum/semen
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 24424039Haverfield JT, Meachem SJ, Nicholls PK, Rainczuk KE, Simpson ER, Stanton PG. Differential permeability of the blood-testis barrier during reinitiation of spermatogenesis in adult male rats. Endocrinology. 2014 Mar;155(3):1131-44. doi: 10.1210/en.2013-1878. Epub 2013 Jan 1.
- Background: PubMed 27353840Stanton PG. Regulation of the blood-testis barrier. Semin Cell Dev Biol. 2016 Nov;59:166-173. doi: 10.1016/j.semcdb.2016.06.018. Epub 2016 Jun 25.
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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.
Anat Hershko klement, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test (CMV IGG, Anti sperm antibody, Testosterone levels) in people with Male Infertility, run by Hadassah Medical Organization at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Aug 2022. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chana Adler Lazarovits, MD (00 972 50 8779068, chanaa@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV antibody ratio serum/semen (time frame: Through study completion, an average of 1 year). 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 NCT05302856, which also lists 2 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 23 Aug 2022.