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Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Mefenamic acid or Hyoscine or placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Saline infusion sonohysterography, Pain, Hyoscine, Mefenamic acid, women

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Siriraj hospital Mahidol university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyoscine, Mefenamic acid, Placebo

Arm Description

Blind randomization to three groups. Mefenamic acid group Hyoscine group Placebo group

Outcomes

Primary Outcome Measures

Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography

Secondary Outcome Measures

Patients satisfaction during saline infusion sonohysterography

Full Information

First Posted
January 31, 2010
Last Updated
February 1, 2010
Sponsor
Mahidol University
Collaborators
Siriraj Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01060696
Brief Title
Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women
Official Title
Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women. A Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University
Collaborators
Siriraj Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Saline infusion sonohysterography, Pain, Hyoscine, Mefenamic acid, women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyoscine, Mefenamic acid, Placebo
Arm Type
Experimental
Arm Description
Blind randomization to three groups. Mefenamic acid group Hyoscine group Placebo group
Intervention Type
Drug
Intervention Name(s)
Mefenamic acid or Hyoscine or placebo
Other Intervention Name(s)
Ponstan (Mefenamic acid), Buscopan (Hyoscine-N-butylbromide)
Intervention Description
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 Outcome Measure Information:
Title
Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography
Time Frame
Before, during and after the procedure
Secondary Outcome Measure Information:
Title
Patients satisfaction during saline infusion sonohysterography
Time Frame
After the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Singpetch Suksompong, Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospital Mahidol university
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women

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