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

NCT ID: NCT05302856

Last Updated: 2022-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Male Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Presumably fertile male patients going through ART treatment

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

Peripheric blood extraction

Subfertile/infertile male patients with abnormal semen analysis

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

Peripheric blood extraction

Male patients suffering from unexplained infertility

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

Peripheric blood extraction

Interventions

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

Peripheric blood extraction

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Chana Adler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Chana Adler Lazarovits, MD

Role: CONTACT

00 972 50 8779068

Anat Hershko klement, MD

Role: CONTACT

Facility Contacts

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Hadas Lemberg, PhD

Role: primary

00 972 2 6777572

References

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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.

Reference Type BACKGROUND
PMID: 24424039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27353840 (View on PubMed)

Other Identifiers

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IGGSEMEN-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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