Optimal Balloon Catheter Placement During Sonohysterography

Royan Institute

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Device: sonohysterography with inflated catheter in cervical cavity; Device: sonohysterography with inflated catheter in uterine cavity

Study type: Interventional

Funder types: Other

Identifiers

NCT01936116

Royan-Emb-016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 2 patient groups

patients with intrauterine balloon catheter placement

Experimental group

Description:

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

Treatment:

Device: sonohysterography with inflated catheter in uterine cavity

patients with intracervical balloon catheter placement

Active Comparator group

Description:

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

Treatment:

Device: sonohysterography with inflated catheter in cervical cavity