We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Trichomonas Vaginalis Genotyping in Upper Egypt

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03614286
Recruitment Status : Unknown
Verified August 2018 by nasser mohamed abdelkareem, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : August 7, 2018
Information provided by (Responsible Party):
nasser mohamed abdelkareem, Assiut University

Brief Summary:
The worldwide incidence of trichomoniasis was estimated to be 276.4 million new cases per year in 2008 .In Egypt, the reported prevalence rate ranges from 5% to 79.16% we aim to study genetic variability of Trichomonas vaginalis using PCR

Condition or disease Intervention/treatment
Trichomonas Vaginalis Genotyping in Upper Egypt Vaginitis Trichomonal Diagnostic Test: culture and pcr

Detailed Description:

In women, trichomoniasis has a wide range of presentations, from asymptomatic to acute or chronic inflammatory disease they include urethral discharge and dysuria. Among women, common sites of infection include the vagina, urethra and endocervix. Symptoms include vaginal discharge (which is often diffuse, malodorous, yellow-green), dysuria, itching, vulvar irritation and abdominal pain. The normal vaginal pH is 4.5, but with TV infection this increases markedly, often to >5 Colpitis macularis or strawberry cervix is seen in about 5 % of women, though with colposcopy this rises to nearly 50 % .Other complications include infection of the adnexa, endometrium, and Skene and Bartholin glands. In men, it can cause epididymitis, prostatitis, and decreased sperm cell motility .

A lot of risk factors of infection are related to age, educational level, residence, race/ethnicity, marital status, number of sex partners, use of condom/IUD, history of sexually transmitted diseases and presence of vaginal discharge .

Traditionally physicians make the diagnosis based on clinical grounds, but in women, the characteristics of the vaginal discharge, including color and odor, are poor predictors of T. vaginalis. Since no symptom alone or in combination is sufficient to diagnose T. vaginalis infection reliably, laboratory diagnosis is necessary ,Diagnosis of T. vaginalis infection is established by the traditional method wet mount test, in which "corkscrew" motility observed . Anyhow, culture has long been the gold standard for diagnosing T. vaginalis infection , with a sensitivity range from 85-95 % . Other used methods for diagnosis include enzyme-linked immunosorbent assay , staining methods latex agglutination , immunochromatography and nucleic acid amplification tests .In order to develop protocol for the diagnosis of trichomoniasis, ideal test should have high sensitivity and specificity and be easily available, simple to perform, and inexpensive Knowledge of the genetic characteristics of T. vaginalis populations is valuable for the prevention and control of trichomoniasis in humans .

The lengths of specific regions in the small subunit of nuclear ribosomal RNA (SSU nrRNA, also known as 18S rRNA) are not conserved among different groups, and these differences can be significant. Thus, 18S rRNA is suitable to study genetic variations and genotypes of organisms.

The use of reliable classification and genetic characterization methods can help to clarify the ambiguities in this field.

Multiple approaches to typing Trichomonas isolates have been described; antigenic characterization, ribosomal gene and intergenic region sequence polymorphisms, random amplified polymorphic DNA analysis, and restriction fragment length polymorphism .These studies produced differing results, even when using similar techniques, in attempting to demonstrate concordance between parasite genotypes and phenotypic expressions during infection, such as virulence and metronidazole resistance. The T. vaginalis genome composition provides a potential explanation for this difficulty in correlating genotype with phenotype.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Other
Official Title: Trichomonas Vaginalis Genotyping in Upper Egypt
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Intervention Details:
  • Diagnostic Test: culture and pcr
    The swab immersed in Diamond's Modified medium culture tube and squeezed for cultivation and examined daily with a light microscope to identify T. vaginalis Samples from culture will be placed in 1 ml of a commercial PCR transport medium (AMPLICOR; Roche Diagnostic Systems, Branchburg, N.J.) and kept at 4°C until arrival at the laboratory within 4 days of collection. An equal volume of specimen diluent (AMPLICOR) was added to the sample , and the preparation was mixed, incubated at room temperature for 10 min, and stored at -70°C until tested.
    Other Name: PCR

Primary Outcome Measures :
  1. study genetic variability of Trichomonas vaginalis using PCR [ Time Frame: 1year ]
    detection of TV in vaginal swap then PCR done to detect genetic diversity

Biospecimen Retention:   Samples With DNA
vaginal swab

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   non virgins females
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
one group from 20 patients

Inclusion Criteria:

  • females ,non virgins,complain from vaginitis ,at reproductive age and attending to sohag general hospital outpatient clinic of gynecology and obstetric

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614286

Layout table for location contacts
Contact: Ahmed Kamal Dyab, Professor +201018614645 ahmedsaf2001@yahoo.com
Contact: Mohamed Essa, Professor +201006329838 essa3eg@yahoo.com

Sponsors and Collaborators
Assiut University
Layout table for additonal information
Responsible Party: nasser mohamed abdelkareem, Assistant Lecturer of Medical Parasitology, Assiut University
ClinicalTrials.gov Identifier: NCT03614286    
Other Study ID Numbers: T V Genotyping
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Trichomonas Infections
Trichomonas Vaginitis
Vaginal Diseases
Protozoan Infections
Parasitic Diseases