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

Study Overview
=================
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: 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.

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

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Presumably fertile male patients going through ART treatment<br> | Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)<br>* Peripheric blood extraction<br>|
| Experimental: Subfertile/infertile male patients with abnormal semen analysis<br> | Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)<br>* Peripheric blood extraction<br>|
| Experimental: Male patients suffering from unexplained infertility<br> | Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)<br>* Peripheric blood extraction<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV antibody ratio serum/semen |  | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sperm, blood testis barrier, cmv antibody, unexplained infertility