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Warm Contrast Media for Pain Reduction During Hystersalpingography

S

Shaare Zedek Medical Center

Status

Unknown

Conditions

Infertility

Treatments

Procedure: Temperature of contrast medium

Study type

Interventional

Funder types

Other

Identifiers

NCT00391781
WARMHSG.CTIL

Details and patient eligibility

About

The aim of this study is to compare between body-temperature to room-temperature contrast media used during hysterosalpingography. We hypothesize that warmed medium will reduce pain associated with the procedure.

Full description

Infertility occurs in about 15% of all couples. One of the common methods for evaluation of mechanical infertility is hysterosalpingography (HSG). Several reports have shown that this common procedure is associated with moderate pain, i.e. around 5 on a visual analog scale (VAS)of 1-10. It is therefore important to find modes for pain reduction for HSG. According to a report on sonohydrosonograpy, a similar technique using sonography, insertion of media warmed to body temperature into the uterus significantly reduced the pain during the procedure compared with media at room-temprature. The use of room-temperature media is the routine in our institution, as well as in many others. A comparison between the media at different temperatures has not been reported so far.

We plan to perform a prospective trial in which patients referred for HSG will be randomized to the procedure using either warmed or room-temperature media. we will asses pain levels using VAS during the procedure.

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis: infertility
  • sex: female
  • age: 18-45

Exclusion criteria

  • active pelvic inflammotory disease
  • known sensitivity to contrast medium

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Avi Tsafrir, MD

Data sourced from clinicaltrials.gov

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