Hysterosalpingo-foam sonography as an Essure confirmation test

Hysterosalpingo-Foam Sonography vs. HysteroSalpinGography as an Essure hysteroscopic sterilization confirmation test

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13414740

Enrollment

Registered

2016-07-15

Start date

2013-01-24

Completion date

Unknown

Last updated

2019-02-11

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

Conditions

Essure hysteroscopic sterilization Pregnancy and Childbirth

Interventions

Essure hysteroscopic sterilization is performed in an outpatient setting. One hour before the procedure, patient takes premedication with diazepam 5 mg orally and ketoprofen 100 mg rectally.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients undergone Essure hysteroscopic sterilization for pregnancy prevention.

Exclusion criteria

Exclusion criteria: 1. Patients who decline transvaginal ultrasound examination 2. Patients who decline hysterosalpingo-foam sonography examination 3. Patients who decline hysterosalpingography 4. Patients who decline to fill in a questionnaire 5. Patients who wish to be excluded from the study

Design outcomes

Primary

Measure	Time frame
Comparison of Fallopian tubes patency performed with both hysterosalpingo-foam sonography (HyFoSy) and hysterosalpingography (HSG) 3 months after Essure hysteroscopic sterilization.	—

Secondary

Measure	Time frame
1. Efficacy of Essure hysteroscopic sterilization, determined by hysterosalpingography 3 months after Essure hysteroscopic sterilization 2. Complications of Essure hysteroscopic sterilization, determined by hysteroscopist at the time of Essure hysteroscopic sterilization and by the patient at the 3 months follow up visit 3. Pain at Essure hysteroscopic sterilization, measured using the visual analogue score (VAS) at the time of the procedure 4. Patient satisfaction with Essure hysteroscopic sterilisation, measured by visual analogue score (VAS) 3 months after the procedure 5. Pain at hysterosalpingo-foam sonography (HyFoSy) and at hysterosalpingography (HSG), measured by visual analogue score (VAS) at the time of the procedures 6. Determine, how transvaginal ultrasound (US) assessment of Essure micro-insert position corresponds with tubal patency, determined by US and hysterosalpingography (HSG) 3 months after Essure hysteroscopic sterilization	—

Measure

Time frame

1. Efficacy of Essure hysteroscopic sterilization, determined by hysterosalpingography 3 months after Essure hysteroscopic sterilization 2. Complications of Essure hysteroscopic sterilization, determined by hysteroscopist at the time of Essure hysteroscopic sterilization and by the patient at the 3 months follow up visit 3. Pain at Essure hysteroscopic sterilization, measured using the visual analogue score (VAS) at the time of the procedure 4. Patient satisfaction with Essure hysteroscopic sterilisation, measured by visual analogue score (VAS) 3 months after the procedure 5. Pain at hysterosalpingo-foam sonography (HyFoSy) and at hysterosalpingography (HSG), measured by visual analogue score (VAS) at the time of the procedures 6. Determine, how transvaginal ultrasound (US) assessment of Essure micro-insert position corresponds with tubal patency, determined by US and hysterosalpingography (HSG) 3 months after Essure hysteroscopic sterilization

—

Countries

Slovenia

Outcome results

None listed

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