NCT03792438

Brief Summary

This study aims to assess the relation between the vascularity of uterine septum and obstetric performance with Transvaginal 3D Power Doppler Ultrasound

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 27, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 26, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
Last Updated

January 3, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

December 26, 2018

Last Update Submit

January 2, 2019

Conditions

Septum; Uterus

Outcome Measures

Primary Outcomes (1)

  • Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium

    Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium and its relationship to either primary infertility or recurrent abortion

    About 18 months

Interventions

Transvaginal 3D Power Doppler UltrasoundDIAGNOSTIC_TEST

Samsung H60 ultrasound machine with 4-9 MHz volume transducer using VOCAL system and Histogram Facility

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with primary infertility or recurrent abortion attending to Early Cancer Detection Unit at Ain Shams Maternity Hospital

You may qualify if:

  • Patients with septate uterus diagnosed by office hysteroscopy

You may not qualify if:

  • Women with previous uterine scar.
  • Women with suspected or confirmed pregnancy.
  • Women with active pelvic infection or old one.
  • Women with abnormal uterine bleeding.
  • Fibroids, adenomyosis or ovarian swelling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 11357, Egypt

Location

Study Officials

  • Mohamed I Amer, MD

    Professor

    STUDY CHAIR

  • Nashwa E Hassan, MD

    Assistant Professor

    STUDY DIRECTOR

  • Mortada E Ahmed, MD

    Lecturer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2018

First Posted

January 3, 2019

Study Start

May 27, 2017

Primary Completion

November 25, 2018

Study Completion

November 25, 2018

Last Updated

January 3, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)