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

Not Applicable

• Conditions: Male Infertility
• Interventions: Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)

• Registration Number: NCT05302856
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study Start: 2022-03-02
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-23
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Presumably fertile male patients going through ART treatment	Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)	-
Subfertile/infertile male patients with abnormal semen analysis	Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)	-
Male patients suffering from unexplained infertility	Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel