Back to resultsCMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
Primary Purpose
Male Infertility
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)
Sponsored by
About this trial
This is an interventional diagnostic trial for Male Infertility focused on measuring sperm, blood testis barrier, cmv antibody, unexplained infertility
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
Sites / Locations
- Hadassah Medical OrganizationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Presumably fertile male patients going through ART treatment
Subfertile/infertile male patients with abnormal semen analysis
Male patients suffering from unexplained infertility
Arm Description
Outcomes
Primary Outcome Measures
CMV antibody ratio serum/semen
Secondary Outcome Measures
Full Information
NCT ID
NCT05302856
First Posted
February 28, 2022
Last Updated
August 22, 2022
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT05302856
Brief Title
CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
Official Title
CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
sperm, blood testis barrier, cmv antibody, unexplained infertility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Presumably fertile male patients going through ART treatment
Arm Type
Experimental
Arm Title
Subfertile/infertile male patients with abnormal semen analysis
Arm Type
Experimental
Arm Title
Male patients suffering from unexplained infertility
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)
Intervention Description
Peripheric blood extraction
Primary Outcome Measure Information:
Title
CMV antibody ratio serum/semen
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chana Adler Lazarovits, MD
Phone
00 972 50 8779068
Email
chanaa@hadassah.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Anat Hershko klement, MD
Email
anathk@hadassah.org.il
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Chana Adler Lazarovits, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
24424039
Citation
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.
Results Reference
background
PubMed Identifier
27353840
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.
Results Reference
background
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CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
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