Comparing two methods for assessing fertility in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• AmsterdamUMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Danah Kamphuis, Msc
• Email: FOil@amsterdamumc.nl
• Phone: +312044444567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.