Optimal Balloon Catheter Placement During Sonohysterography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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patients with intrauterine balloon catheter placement

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

Group Type EXPERIMENTAL

sonohysterography with inflated catheter in uterine cavity

Intervention Type DEVICE

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

patients with intracervical balloon catheter placement

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

Group Type ACTIVE_COMPARATOR

sonohysterography with inflated catheter in cervical cavity

Intervention Type DEVICE

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

Interventions

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sonohysterography with inflated catheter in uterine cavity

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

Intervention Type DEVICE

sonohysterography with inflated catheter in cervical cavity

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

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No