CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05302856

Enrollment

Registered

2022-03-31

Start date

2022-03-02

Completion date

2023-03-31

Last updated

2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Keywords

sperm, blood testis barrier, cmv antibody, unexplained infertility

Brief summary

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: 1. Presumably fertile male patients going through ART treatment (for preimplantation genetic testing (PGT) or female indications). 2. Subfertile/infertile male patients with abnormal semen analysis. 3. 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.

Interventions

DIAGNOSTIC_TESTBlood test (CMV IGG, Anti sperm antibody, Testosterone levels)

Peripheric blood extraction

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* All male patients addressing the infertility unit in Hadassah Mt Scopus for IVF procedure

Exclusion criteria

* Refusal to participate * Male partner utilizing pre cycle frozen sperm sample * Donor sperm cycles * Surgically retrieved sperm

Design outcomes

Primary

Measure	Time frame
CMV antibody ratio serum/semen	Through study completion, an average of 1 year

Countries

Israel

Contacts

Primary ContactChana Adler Lazarovits, MD

chanaa@hadassah.org.il00 972 50 8779068

Backup ContactAnat Hershko klement, MD

anathk@hadassah.org.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026