Tubal Flushing With Oil-based Contrast During HSG in Subfertile Women: Is Early Flushing Effective and Cost-effective as Compared to Delayed Flushing? - H2Oil-timing Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 39
Healthy Volunteers: f
View:
• Women between 18-39 years of age
• Spontaneous menstrual cycle
• Perceived low risk for tubal pathology
• Undergoing fertility work-up
Locations
Other Locations
Netherlands
Amsterdam AMC
RECRUITING
Amsterdam
Contact Information
Primary
V Mijatovic
mijatovic@amsterdamumc.nl
+312044444567
Backup
Danah Kamphuis
d.kamphuis@amsterdamumc.nl
+312044444567
Time Frame
Start Date: 2019-08-22
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 554
Treatments
Experimental: Direct HSG during fertility work-up
Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) incorporated in the fertility work-up
Active_comparator: Delayed HSG 6 months after completing fertility work-up
Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) after a 6 months waiting period after completion of fertility work-up
Related Therapeutic Areas
Sponsors
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Amsterdam UMC, location VUmc