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

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302856
• Other study ID #: IGGSEMEN-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: March 2023

Study information

• Verified date: August 2022
• Source: Hadassah Medical Organization
• Contact: Chana Adler Lazarovits, MD
• Phone: 00 972 50 8779068
• Email: chanaa[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Diagnostic Test:
• Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)
Peripheric blood extraction

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Haverfield JT, Meachem SJ, Nicholls PK, Rainczuk KE, Simpson ER, Stanton PG. Differential permeability of the blood-testis barrier during reinitiation of spermatogenesis in adult male rats. Endocrinology. 2014 Mar;155(3):1131-44. doi: 10.1210/en.2013-1878. Epub 2013 Jan 1. — View Citation

Stanton PG. Regulation of the blood-testis barrier. Semin Cell Dev Biol. 2016 Nov;59:166-173. doi: 10.1016/j.semcdb.2016.06.018. Epub 2016 Jun 25. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV antibody ratio serum/semen		Through study completion, an average of 1 year