NCT05302856

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Male Infertility

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)	Peripheric blood extraction

Timeline

• Start date: 2022-03-02
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-03-31
• Last updated: 2022-08-23

Locations

1 site across 1 country: Israel