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

  • STATUS
    Recruiting
  • End date
    Mar 16, 2023
  • participants needed
    30
  • sponsor
    Hadassah Medical Organization
Updated on 4 October 2022
Accepts healthy volunteers

Summary

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

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.

Details
Condition Male Infertility
Treatment Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)
Clinical Study IdentifierNCT05302856
SponsorHadassah Medical Organization
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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