NCT03614286

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

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

July 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

July 30, 2018

Last Update Submit

August 4, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • study genetic variability of Trichomonas vaginalis using PCR

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

    1year

Interventions

culture and pcrDIAGNOSTIC_TEST

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

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsnon virgins females
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

one group from 20 patients

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29499747BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

vaginal swab

MeSH Terms

Conditions

Trichomonas Vaginitis

Condition Hierarchy (Ancestors)

Trichomonas InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Ahmed Kamal Dyab, Professor

CONTACT

Mohamed Essa, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Medical Parasitology

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 3, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2019

Study Completion

March 1, 2020

Last Updated

August 7, 2018

Record last verified: 2018-08