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Optimal catheter placement during sonohysterography

Pain perception and side effects during sonohysterography with balloon catheters: a randomized comparative study of cervical with uterine catheter placement

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT201309053553N1
Enrollment
300
Registered
2013-10-30
Start date
2012-04-30
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility. Female infertility, unspecified

Interventions

Intervention 1: Intervention group: In this group after introduction of speculum, balloon catheter was inflated in the uterine cavity. Then under sonographic guidance, sterile normal saline (10-50 mL)
Diagnosis
Intervention group: In this group after introduction of speculum, balloon catheter was inflated in the uterine cavity. Then under sonographic guidance, sterile normal saline (10-50 mL) was slowly intr
Control group: In this group after introduction of speculum, balloon catheter was inflated in the cervical canal. Then under sonographic guidance, sterile normal saline (10-50 mL) was slowly introduce

Sponsors

Royan Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Infertile patients who are referred to Royan Institute and undergoing sonohysterography for evaluation of the internal structure of uterine cavity (acquired & congenital abnormalities). Exclusion criteria: Symptoms or signs of active pelvic infection, Abnormal uterine bleeding ,Women with cervical stenosis, Women with each lesions which disrupts catheterization such as large myoma, Risk factors for endometrial cancer

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain perception. Timepoint: At the time of the Balloon inflation and deflation. Method of measurement: 10-point visual analog pain scale.;Vasovagal reaction rate ( Hypotention, sweating, nausea, vomiting, syncope). Timepoint: from inflation of balloon catheter till 30 minutes after deflation. Method of measurement: touching of pulse , sphygmomanometer, observation of respiration , Termometer.

Secondary

MeasureTime frame
Total time required to perform of sonohysterography. Timepoint: During of sonohysterography. Method of measurement: Recording of total time of sonohysterography.;Spontaneous catheter expulsion rate. Timepoint: During of sonohysterography. Method of measurement: Re-Catheter placement rate.;Volume of media required to perform procedure. Timepoint: During of sonohysterography. Method of measurement: Measuring of volume of injected media during sonohysterography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFiroozeh Ahmadi

Royan institute

dr.ahmadi1390@gmail.com+98 21 2356 2446

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026