Is, in infertile women undergoing a basic fertility work-up, tubal flushing with oil-based contrast medium during hysterosalpingography (HSG) cost-effective compared to tubal flushing by hysterosalpingo-foam sonography (HyFoSy)? A randomized controlled trial.

Is, in infertile women undergoing a basic fertility work-up, tubal flushing with oil-based contrast medium during hysterosalpingography (HSG) cost-effective compared to tubal flushing by hysterosalpingo-foam sonography (HyFoSy)? A randomized controlled trial. - FOil Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53875

Enrollment

1102

Registered

2022-12-20

Start date

2023-09-22

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

Tubal flushing tubal patency testing

Interventions

&nbsp

Tubal flushing with oil-based contrast during HSG vs tubal&nbsp

flushing with ExEm Foam during HyFoSy.&nbsp

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria:  - Infertile women or women with oligo-or anovulation - Aged between 18 and 42 years - With indication for tubal patency testing during the fertility work-up - Sufficient understanding of the Dutch or English language - Signed informed consent 

Exclusion criteria

Exclusion criteria:  - Severe male factor with a total motile sperm count <3x106ml (pre-washed) -  Known contrast (iodine) allergy - Women who have had a gynecologic procedure  within the last 30 days - Women with known or suspected reproductive tract  neoplasia 

Design outcomes

Primary

Measure	Time frame
The primary outcome is pregnancy leading to live birth within six months after randomization. Pregnancy is defined as a positive pregnancy tests or a pregnancy shown on ultrasonographic examination. Live birth is defined as the birth of live baby born beyond 24 weeks of pregnancy.	—

Secondary

Measure	Time frame
- Time to pregnancy leading to live birth. Calculated from the day of randomization till the first day of the last menstrual bleeding. - Number of clinical pregnancies, miscarriages, ectopic pregnancies, multiple pregnancies, still births. All within 6 months after randomization. - Number of adverse events within one months after tubal patency testing, e.g. infection, intravasation, thyroid dysfunction. - Procedural pain scores, measured by Visual Analogue Scale (VAS) immediately after tubal patency testing. - Number of fertility treatment cycles (IUI, IVF, ICSI) within 6 months after randomization. - Number of pregnancy complications, e.g. pregnancy induced hypertension, fetal growth restriction. - Neonatal outcomes, e.g. date of birth, sexes, birth weight. - Quality of life, using EQ-5D-5L questionnaire measured 6 months after randomization. - Cost-effectiveness, the effectiveness (pregnancies leading to live births) compared to the costs (including costs from a healthcare perspective (costs for tubal patency testing and fertility treatment) and costs from a societal perspective using the iMedical Productivity Costs Questionnaire (iMPCQ)) for both tubal flushing strategies.	—

Measure

Time frame

- Time to pregnancy leading to live birth. Calculated from the day of randomization till the first day of the last menstrual bleeding. - Number of clinical pregnancies, miscarriages, ectopic pregnancies, multiple pregnancies, still births. All within 6 months after randomization. - Number of adverse events within one months after tubal patency testing, e.g. infection, intravasation, thyroid dysfunction. - Procedural pain scores, measured by Visual Analogue Scale (VAS) immediately after tubal patency testing. - Number of fertility treatment cycles (IUI, IVF, ICSI) within 6 months after randomization. - Number of pregnancy complications, e.g. pregnancy induced hypertension, fetal growth restriction. - Neonatal outcomes, e.g. date of birth, sexes, birth weight. - Quality of life, using EQ-5D-5L questionnaire measured 6 months after randomization. - Cost-effectiveness, the effectiveness (pregnancies leading to live births) compared to the costs (including costs from a healthcare perspective (costs for tubal patency testing and fertility treatment) and costs from a societal perspective using the iMedical Productivity Costs Questionnaire (iMPCQ)) for both tubal flushing strategies.

—

Countries

Netherlands

Contacts

Public ContactM. Mijatovic

Amsterdam UMC

foil@amsterdamumc.nl0204444444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)