Clinical Trial: Antispasmodic Drug for Diagnosis Proximal Tubal Occlusion on Hysterosalpingography

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Premedication Hyoscine-N-butylbromide Before Hysterosalpingography for Diagnosis of Proximal Tubal Obstruction in Infertile Women : A Randomized Double-Blind Controlled Trial

Brief Summary: This study finds premedication Hyoscine-N-butylbromide before hysterosalpingography have a potential effect for diagnosis of proximal tubal obstruction in infertile women. The investigators did a double-blind, randomized placebo-controlled trial

Detailed Summary:

Infertility is a common gynecologic problem in reproductive medicine. The causes of female infertile can divided into ovulatory dysfunction, tubal and pelvic pathology, unexplained infertility and unusual problems. About 30-35% of case of infertility are caused by the tubal factor and tubal disease is an important cause of infertility and should be specifically excluded(1). Methods for evaluation of the fallopian tube pathology include the Hysterosalpingography(HSG), Saline infusion sonography(SIS) and Laparoscopy with chromopertubation etc(2-3).

Laparoscopy with chromopertubation is considered the definitive test for evaluating tubal disease and allows for the detection of other intraabdominal causes of infertility. However, laparoscopy is expensive, time consuming, limited in some centers, and unpleasant for the patient. More importantly many patients have anesthetic and surgical complications that require hospital admission(4). Therefore, HSG has been most commonly used for routine screening in infertility for evaluation of tubal patency. It is a simple, noninvasive and inexpensive technique. HSG is the standard first-line test to evaluate tubal patency(5-7).

HSG is an X-ray procedure that is used to view the inside of the uterus and fallopian tubes. HSG for investigating tubal patency has moderate sensitivity 65% but excellent specificity 83% in the infertile population. The PPV and NPV of HSG are 38% and 94%, respectively(8-9). However, it can have a false positive diagnosis if the HSG indicates occlusion, there may be a good chance 60% that the tubes are actually patent, and if the HSG demonstrates patency there is a little chance 5% that the tubes are occluded(10). There are several factors leading to a false diagnosis of tubal occlusion by using HSG. The most common factor cited is a cornual spasm(11), there could
Sponsor: Mahidol University

Current Primary Outcome: number result diagnosis of proximal tubal occlusion [ Time Frame: up to 24 weeks ]

To evaluate rate diagnosis of proximal tubal occlusion compare between Hyoscine group and placebo group before HSG.


Original Primary Outcome: Pain score by Visual Analog scale(VAS) [ Time Frame: intraoperative ]

Self reported pain intensity


Current Secondary Outcome:

  • number of true occlusion or false occlusion [ Time Frame: up to 24 weeks ]
    To evaluate false positive results of proximal tubal occlusion from HSG compare between study and control groups.
  • number of participants with treatment-related adverse effects of drug and procedure [ Time Frame: up to 24 weeks ]
    such as dizziness, syncope, tachycardia, nausea, vomiting, pelvic pain, bleeding


Original Secondary Outcome:

  • Incidence of cornual obstruction(compare the result of hysterosalpingography in each groups) [ Time Frame: intraoperative ]
    cornual obstruction may cause from cramping or cornual spasm
  • number of participants with treatment-related adverse effects of drug and procedure [ Time Frame: intraoperative ]
    such as dizziness, syncope, tachycardia, nausea, vomiting, pelvic pain, bleeding


Information By: Mahidol University

Dates:
Date Received: November 21, 2015
Date Started: June 2016
Date Completion:
Last Updated: April 16, 2017
Last Verified: November 2016