NCT02399501

Brief Summary

Prospective comparative study including 100 infertile patients with suspected uterine lesion. 2D ultrasound, sonohysterography , 3D ultrasound and hysteroscopy will be done to evaluate uterine cavity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

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

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

March 5, 2015

Last Update Submit

March 18, 2017

Conditions

Infertility

Keywords

2D ultrasound3D ultrasoundsonohysterographyhysteroscopyUterine factor of infertility

Outcome Measures

Primary Outcomes (1)

  • detection of uterine lesion

    at time of hystroscopy

Study Arms (1)

uterine lesion ultrasound, hysteroscopy

EXPERIMENTAL

evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy

Procedure: hysteroscopyDevice: two dimensional ultrasoundDevice: saline sonohysterographyDevice: three dimensional ultrasound

Interventions

hysteroscopyPROCEDURE

Hysteroscopy is done under general anesthesia. The hysteroscopy used is rigid continuous flow diagnostic hysteroscopy (Tuttligen, Karl Storz, Germany). It has a 30º panoramic optic which is 4 mm in diameter and the diagnostic continuous flow outer sheath is 6.5 mm in diameter.

uterine lesion ultrasound, hysteroscopy
two dimensional ultrasoundDEVICE

Examination is performed after emptying of the bladder in dorsal lithotomy position .The probe is introduced into the posterior fornix of the vagina, then the following structures are examined, the uterus for site, size and mobility, the myometrium for fibroids and adenomyosis, the endometrium for uniformity, polyps, submucous fibroids and intrauterine adhesions, the cervix for nabothian follicles and polyps, the adenexa and ovaries for site, size, mobility, follicles, cysts and corpus luteum

Also known as: (Sonoace 5000)
uterine lesion ultrasound, hysteroscopy
saline sonohysterographyDEVICE

sterile speculum is introduced and the vagina and cervix is cleaned with povidone iodine 10%. Cook ET (embryo transfer) catheter is used. . After introduction of the catheter into the cervix, a twenty milliliter syringe which will be prefilled with the distending media (saline) then fitted to the catheter. The speculum is removed and endovaginal probe is introduced in the posterior vaginal fornix

Also known as: (Sonoace 5000)
uterine lesion ultrasound, hysteroscopy
three dimensional ultrasoundDEVICE

The uterus is visualized in the longitudinal plane, the ultrasound probe is kept steady and the patient is asked to lie still on the examination bed. The volume mode is switched on. Three D volume is generated by the automatic rotation of the mechanical transducer through 360º. The acquired volume is in the shape of a transacted cone with a depth of 4.3 - 8.6 cm and a vertical angle α = 90º. Using the medium line density, the typical acquisition time is a round 10 seconds

Also known as: (Medison, Voulson 530 D-MT ultrasound machine)
uterine lesion ultrasound, hysteroscopy

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Suspected uterine factor of infertility

You may not qualify if:

  • tubal, ovarian or male factor of infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Maged

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Ahmed Maged, MD

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 26, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

EG(1)