Is Hysterosalpingo-Foam Sonografie (HyFoSy) een kosteneffectief alternatief voor hysterosalpingografie (HSG) als tubadoorgankelijkheidstest in subfertiele vrouwen?
Completed
- Conditions
- - Tubal patency testing- Subfertile women- Hysterosalpingo-foam sonography (HyFoSy)- Hysterosalpingography (HSG)- Cost-effectiveness- Tubadoorgankelijkheidstest- Subfertiele vrouwen- Hysterosalpingo-foam sonografie (HyFoSy)- Hysterosalpingografie (HSG)- Kosteneffectiviteit
- Registration Number
- NL-OMON28335
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Study protocol publication: J. van Rijswijk, N. van Welie, K. Dreyer et al., “Te FOAM study: is Hysterosalpingo foam sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women? study protocol for a randomized controlled trial for a randomized controlled trial,” BMC Womens Health, vol. 18, no. 64, 2018.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1163
Inclusion Criteria
Between 18-41 years
- Subfertile for at least one year.
Exclusion Criteria
- Anovulation not responding on ovulation induction
- Endometriosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is ongoing pregnancy rates leading to live birth within 12-months after inclusion.
- Secondary Outcome Measures
Name Time Method The secondary outcomes are:<br>- Time to pregnancy<br>- Clinical pregnancy rate<br>- Miscarriage rate<br>- Multiple pregnancy rate<br>- Preterm birth rate<br>- Concordance between HyFoSy and HSG<br>- Direct and indirect costs<br>- Pain scores