NCT05302856

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

March 2, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

February 28, 2022

Last Update Submit

August 22, 2022

Conditions

Male Infertility

Keywords

spermblood testis barriercmv antibodyunexplained infertility

Outcome Measures

Primary Outcomes (1)

  • CMV antibody ratio serum/semen

    Through study completion, an average of 1 year

Study Arms (3)

Presumably fertile male patients going through ART treatment

EXPERIMENTAL
Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)

Subfertile/infertile male patients with abnormal semen analysis

EXPERIMENTAL
Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)

Male patients suffering from unexplained infertility

EXPERIMENTAL
Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)

Interventions

Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)DIAGNOSTIC_TEST

Peripheric blood extraction

Male patients suffering from unexplained infertilityPresumably fertile male patients going through ART treatmentSubfertile/infertile male patients with abnormal semen analysis

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All male patients addressing the infertility unit in Hadassah Mt Scopus for IVF procedure

You may not qualify if:

  • Refusal to participate
  • Male partner utilizing pre cycle frozen sperm sample
  • Donor sperm cycles
  • Surgically retrieved sperm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Related 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.

    PMID: 24424039BACKGROUND

  • 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.

    PMID: 27353840BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Chana Adler Lazarovits, MD

CONTACT

00 972 50 8779068chanaa@hadassah.org.il

Anat Hershko klement, MD

CONTACT

anathk@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 31, 2022

Study Start

March 2, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations

IL(1)