Overview

This trial is active, not recruiting.

Condition infertility
Treatment mefenamic acid or hyoscine or placebo
Sponsor Mahidol University
Collaborator Siriraj Hospital
Start date January 2009
End date March 2010
Trial size 138 participants
Trial identifier NCT01060696, 615/2551

Summary

The infertility patients who are performed saline infusion sonohysterography (SIS) for studying the pathology inside the uterine cavity has pain. From pilot study the pain score is 6.80. It will have more benefits if we can manage this procedure with less or no pain. Many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the procedure.The drugs are safe and easy to administration and chief.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Blind randomization to three groups. Mefenamic acid group Hyoscine group Placebo group
mefenamic acid or hyoscine or placebo Ponstan (Mefenamic acid)
Mefenamic acid 500 mg. single oral use 30 minutes before SIS Hyoscine 10 mg. single oral use 30 minutes before SIS Placebo single oral use 30 minutes before SIS

Primary Outcomes

Measure
Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography
time frame: Before, during and after the procedure

Secondary Outcomes

Measure
Patients satisfaction during saline infusion sonohysterography
time frame: After the procedure

Eligibility Criteria

Female participants from 20 years up to 40 years old.

Inclusion Criteria: - infertility female - no history of HSG or Hysteroscopy Exclusion Criteria: - vaginal or pelvic infection - abnormal Pap smear - contraindications for Mefenamic acid including upper and lower GI ulcers, bleeding disorder, Asthma or allergies, renal disease, using Warfarin,Aspirin, Lithium, history of Mefenamic acid or Hyoscine allergies

Additional Information

Official title Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women. A Double Blind Randomized Controlled Trial
Principal investigator Singpetch Suksompong, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Mahidol University.