NCT01936116

Brief Summary

Saline infusion sonohysterography and other intrauterine investigations methods may cause uterine cramping, pain and vasovagal reactions. According to few of previous studies the position of catheter placement can affect the magnitude of pain and amount of saline required during the sonohysterography. The purpose of this double blind control trial study is to assess whether the location of the balloon catheter either the uterus or cervix during sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2012

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 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 6, 2014

Status Verified

February 1, 2012

Enrollment Period

1.3 years

First QC Date

August 25, 2013

Last Update Submit

May 4, 2014

Conditions

Infertility

Keywords

Sonohysterographycatheter placementpain magnitudevasovagal reaction

Outcome Measures

Primary Outcomes (3)

  • perceived Pain

    inflation of the balloon \& deflation of the balloon by a 10-point visual analog pain scale

    during sonohysterography

  • Vasovagal reactions

    Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients During procedure .

    During sonohysterography

  • vasovagal reaction

    Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients 30 minutes after procedure .

    30 minutes after sonohysterography

Secondary Outcomes (2)

  • Saline volume

    during sonohysterography

  • time of procedure

    during sonohysterography

Study Arms (2)

patients with intrauterine balloon catheter placement

EXPERIMENTAL

In this group, during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity

Device: sonohysterography with inflated catheter in uterine cavity

patients with intracervical balloon catheter placement

ACTIVE COMPARATOR

During the procedure of sonohysterography balloon catheter is inflated in the cervical canal

Device: sonohysterography with inflated catheter in cervical cavity

Interventions

sonohysterography with inflated catheter in uterine cavityDEVICE

during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity

patients with intrauterine balloon catheter placement
sonohysterography with inflated catheter in cervical cavityDEVICE

During the procedure of sonohysterography balloon catheter is inflated in the cervical canal

patients with intracervical balloon catheter placement

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile patients who will be referred to Royan institute for sonohysterography to evaluate the internal structure of uterine cavity (acquired \& congenital abnormalities) are included in this prospective comparative study.

You may not qualify if:

  • Symptoms of active pelvic infection
  • Abnormal uterine bleeding
  • Women with cervical stenosis
  • Women with each lesions which disrupts catheterization such as large myoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

MeSH Terms

Conditions

InfertilitySyncope, Vasovagal

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Fatemeh Zafarani, MSc

    Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine

    STUDY DIRECTOR

  • Firoozeh Ahmadi, MD

    Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2013

First Posted

September 5, 2013

Study Start

May 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

May 6, 2014

Record last verified: 2012-02

Locations

IR(1)