NCT01537276

Brief Summary

As an essential step of the infertile work-up, hysterosalpingogram (HSG) has some advantages including the lack of need for anesthesia, a non-invasive procedure with less cost and relative easy to put into practice. However, it would be failed to detect the extra-tubal and peritoneal pathology and would be also difficult to distinguish the obstruction caused by the spasm of intramural segment. Obviously, imaging quality plays a key role in diagnostic accuracy of the HSG, studies had taken four roentgenograms and combined with the fluoroscopy were reported a higher sensitivity and specificity than those only taken two images in the examination. And hybridized radiography with CT or MRI system may provide the good-quality of the HSG. It is also reported that the sonosalpingography (SSG), which detect the tubal patency in real time, can show pelvic pathologies better than HSG. However, no parallel study was designed to verify the hypothesis that combined the fluoroscopy and taken more images can improving the diagnostic quality of the HSG. The aim of this study is to evaluate whether the accuracy of HSG can be improved by real-time evaluating under the fluoroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

1.8 years

First QC Date

February 12, 2012

Last Update Submit

February 22, 2012

Conditions

Infertility

Keywords

hysterosalpingographyFluoroscopydiagnostic accuracy

Outcome Measures

Primary Outcomes (1)

  • diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal pathologies

    The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of HSG for diagnosis of tubal pathlogies. The pathlogies of tube is classified as the normal HSG, the proximal tubal obstruction, the hydrosalpinx (distal tubal obstruction), and the peritubal adhesions (at least one tube is patent) ,which is confirmed by laparoscopy in six month after HSG.

    participants will be followed by laparoscopy in 6 month after HSG

Secondary Outcomes (1)

  • diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal patency

    participants will be followed by laparoscopy in 6 month after HSG

Study Arms (2)

real-time fluoroscopy

EXPERIMENTAL

evaluating the tubal patency and pathology under fluoroscopy real-timely

Procedure: diagnose under real-time fluoroscopy

respective image

NO INTERVENTION

evaluating the tubal patency and pathology by Two supine and two oblique static images.

Interventions

diagnose under real-time fluoroscopyPROCEDURE

radiologists evaluating the tubal patency under fluoroscopy real-timely.Findings of fluoroscopy were blind to the investigators when the static radiographs were re-analyzed by the same team of radiologists.

Also known as: dynamic fluoroscopy
real-time fluoroscopy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women seeking for a infertility laparoscopy

You may not qualify if:

  • acute low reproductive duct infection
  • a known hypersensitivity to iodine
  • genital bleeding or malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, 317000, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ying-Zi Mao, MD

    Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Center for reproductive medicine

Study Record Dates

First Submitted

February 12, 2012

First Posted

February 23, 2012

Study Start

January 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations

CN(1)