CClinicalTrials.gg
Status unknownNCT03614286Updated Aug 7, 2018

Trichomonas Vaginalis Genotyping in Upper Egypt

An observational study in Trichomonas Vaginalis Genotyping in Upper Egypt and Vaginitis Trichomonal, sponsored by Assiut University. Status unknown. Open to female participants. Per ClinicalTrials.gov, last updated 2018-08-07.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
20
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Trichomonas Vaginalis Genotyping in Upper Egypt
  • Vaginitis Trichomonal
03

In context

Trichomonas Infections

32 studies on the registry are indexed under Trichomonas Infections; 5 are open to participants now.

This study's planned enrollment of 20 is below the median of 364 across 13 observational studies indexed under Trichomonas Infections.

Browse Trichomonas Infections studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
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

Exclusion Criteria:

-

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testculture 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.

    Also known as: PCR

06

What researchers measure

Primary outcomes

  1. study genetic variability of Trichomonas vaginalis using PCR

    detection of TV in vaginal swap then PCR done to detect genetic diversity

    Time frame: 1year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Zhang Z, Kang L, Wang W, Zhao X, Li Y, Xie Q, Wang S, He T, Li H, Xiao T, Chen Y, Zuo S, Kong L, Li P, Li X. Prevalence and genetic diversity of Trichomonas vaginalis clinical isolates in a targeted population in Xinxiang City, Henan Province, China. Parasit Vectors. 2018 Mar 2;11(1):124. doi: 10.1186/s13071-018-2753-4. PubMed 29499747 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03614286
Lead sponsor
Assiut University
Responsible party
nasser mohamed abdelkareem (Assistant Lecturer of Medical Parasitology, Assiut University) — Principal investigator
First posted
Aug 3, 2018
Start date
Oct 2018 (estimated)
Primary completion
Oct 2019 (estimated)
Completion
Mar 2020 (estimated)
Last update
Aug 7, 2018

Study contacts

Ahmed Kamal Dyab, Professor
Contact
ahmedsaf2001@yahoo.com
+201018614645
Mohamed Essa, Professor
Contact
essa3eg@yahoo.com
+201006329838

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion