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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05302856
Other study ID # IGGSEMEN-HMO-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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