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Optimal Balloon Catheter Placement During Sonohysterography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01936116
First Posted: September 5, 2013
Last Update Posted: May 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royan Institute
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Further study details as provided by Royan Institute:

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

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

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


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

  • time of procedure [ Time Frame: during sonohysterography ]
    Evaluation the total time that is needed for sonohysterography.


Enrollment: 300
Study Start Date: May 2012
Study Completion Date: October 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936116


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
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:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01936116     History of Changes
Other Study ID Numbers: Royan-Emb-016
First Submitted: August 25, 2013
First Posted: September 5, 2013
Last Update Posted: May 6, 2014
Last Verified: February 2012

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

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