Is Hysterosalpingo-Foam Sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women?

Phase 4

Completed

• Conditions: testing if the fallopian tubes are open; Tubal patency testing; 10033283; 10029903

• Registration Number: NL-OMON47620
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1163

Inclusion Criteria

- Women between 18-41 years
- Subfertile for at least one year.
- Valid indication for patency testing in the fertility work-up or before
intra-uterine insemination treatment.

Exclusion Criteria

- Anovulation not responding on ovulation induction
- Endometriosis
- Severe male factor with a Total motile sperm count <1x106/ml
- Known contrast (iodine) allergy
- If not willing or able to sign the informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ongoing pregnancy rates leading to live birth within 12-months after<br /><br>inclusion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Time to pregnancy<br /><br>- Clinical pregnancy rate<br /><br>- Miscarriage rate<br /><br>- Multiple pregnancy rate<br /><br>- Preterm birth rate<br /><br>- Concordance between HyFoSy and HSG<br /><br>- Sensitivity and specificity of HyFoSy and HSG<br /><br>- Procedure time of tubal patency test<br /><br>- Direct and indirect costs<br /><br>- Preference and pain scores</p><br>