Comparing two methods for assessing fertility in women
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)?
This study is testing whether a common fertility test using oil-based contrast can help women have more babies compared to a foam-based test.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1102 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05882188 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and cost-effectiveness of two methods for assessing tubal patency in women undergoing fertility work-up: hysterosalpingography (HSG) with oil-based contrast and hysterosalpingo-foam sonography (HyFoSy) with ExEm Foam. The main objective is to determine whether HSG leads to more live births compared to HyFoSy. The study is designed as a multicenter randomized controlled trial, aiming to provide insights into the safety and economic implications of both approaches. By comparing these methods, the study seeks to enhance fertility outcomes and reduce the need for expensive fertility treatments.
Who should consider this trial
Good fit: Ideal candidates include infertile women or those with oligo-or anovulation who require tubal patency testing.
Not a fit: Patients with severe male factor infertility or known reproductive tract neoplasia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to higher live birth rates for women undergoing fertility assessments.
How similar studies have performed: Previous studies have shown that oil-based contrast during HSG may lead to better pregnancy outcomes, but the comparison with HyFoSy is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infertile women or women with oligo-or anovulation * Indication for tubal patency testing during the fertility work-up * Sufficient understanding of the Dutch or English language * Signed informed consent 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
Where this trial is running
Amsterdam
- AmsterdamUMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Danah Kamphuis, Msc
- Email: FOil@amsterdamumc.nl
- Phone: +312044444567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.