CompletedPhase 4

Optimal Balloon Catheter Placement During Sonohysterography

Iran300 participantsStarted 2012-05

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

perceived Pain

Timeframe: during sonohysterography

Vasovagal reactions

Timeframe: During sonohysterography

vasovagal reaction

Timeframe: 30 minutes after sonohysterography

Trial details

NCT IDNCT01936116

SponsorRoyan Institute

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2013-09

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