Optimal Balloon Catheter Placement During Sonohysterography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Royan Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01936116
First received: August 25, 2013
Last updated: September 1, 2013
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Infertility
Device: sonohysterography with inflated catheter in uterine cavity
Device: sonohysterography with inflated catheter in cervical cavity
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pain Perception and Side Effects During Sonohysterography With Balloon Catheters: a Randomized Comparative Study of Cervical With Uterine Catheter Placement

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • perceived Pain [ Time Frame: during sonohysterography ] [ Designated as safety issue: Yes ]
    inflation of the balloon & deflation of the balloon by a 10-point visual analog pain scale

  • Vasovagal reactions [ Time Frame: During sonohysterography ] [ Designated as safety issue: Yes ]
    Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients During procedure .

  • vasovagal reaction [ Time Frame: 30 minutes after sonohysterography ] [ Designated as safety issue: Yes ]
    Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients 30 minutes after procedure .


Secondary Outcome Measures:
  • Saline volume [ Time Frame: during sonohysterography ] [ Designated as safety issue: Yes ]
    Evaluation the saline volume that is required for sonohisterography

  • time of procedure [ Time Frame: during sonohysterography ] [ Designated as safety issue: Yes ]
    Evaluation the total time that is needed for sonohysterography.


Estimated Enrollment: 300
Study Start Date: May 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients with intrauterine balloon catheter placement
In this group, during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity
Device: sonohysterography with inflated catheter in uterine cavity
during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity
Active Comparator: patients with intracervical balloon catheter placement
During the procedure of sonohysterography balloon catheter is inflated in the cervical canal
Device: sonohysterography with inflated catheter in cervical cavity
During the procedure of sonohysterography balloon catheter is inflated in the cervical canal

Detailed Description:

The proposal of study approved by the investigators institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. A total of 300 infertile women undergoing sonohysterography will be randomized to intrauterine or intracervical balloon catheter placement. The examination is scheduled in the early follicular phase of menstrual cycle, immediately after cessation of menstrual flow and before day 10. After preparation of patient, a 2 lumen 6-French flexible catheter is introduced into the cervical canal and balloon at the catheter tip is placed in the lower uterine segment or 1 cm into cervical canal and inflated with 1 mL of sterile saline solution. Under sonographic guidance, sterile normal saline solution (10-50 mL) is slowly introduced into the cavity until an adequate distention of the uterine cavity is obtained. Three-dimensional ultrasound scanned volumes are recorded. Patients are asked to assess their level of pain at the time of the balloon inflation and deflation using a 10-point visual analog pain scale. Patients are checked for the sign and symptoms of vasovagal reaction during and 30 minutes after procedure. Outcome measures will be assessed based on the intent-to-treat principle.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclusion Criteria:

    • Symptoms of active pelvic infection
    • Abnormal uterine bleeding
    • Women with cervical stenosis
    • Women with each lesions which disrupts catheterization such as large myoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01936116

Contacts
Contact: Nasser Aghdami, MD,PhD (+98)22339913 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD( (+98)23562000 ext 414 Leara91@gmail.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    (+98)22339913    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    (+98)235622000 ext 414    Leara91@gmail.com   
Principal Investigator: Ahmad Vosough, MD         
Sub-Investigator: Saeed Hesam, PhD         
Sub-Investigator: Hadieh Haghighi, BSc         
Sub-Investigator: Maedeh Niknejhad, BSc         
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Fatemeh Zafarani, MSc Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine
Principal Investigator: Firoozeh Ahmadi, MD Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01936116     History of Changes
Other Study ID Numbers: Royan-Emb-016
Study First Received: August 25, 2013
Last Updated: September 1, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Sonohysterography
catheter placement
pain magnitude
vasovagal reaction

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014