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

Hadassah Medical Center

Status: Enrolling

Conditions: Male Infertility

Treatments: Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)

Study type: Interventional

Funder types: Other

Identifiers

NCT05302856

IGGSEMEN-HMO-CTIL

Details and patient eligibility

About

To assess whether the presence of Cytomegalovirus (CMV) Immunoglobulin G (IGG) antibodies in semen is a reliable predictor of male subfertility or infertility.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Presumably fertile male patients going through ART treatment

Experimental group

Treatment:

Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)

Subfertile/infertile male patients with abnormal semen analysis

Experimental group

Treatment:

Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)

Male patients suffering from unexplained infertility

Experimental group

Treatment:

Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)