Determining the best timing for tubal flushing in women seeking pregnancy
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
This study is testing if doing a special procedure to clear blocked fallopian tubes right away can help women trying to get pregnant have more ongoing pregnancies and get pregnant faster compared to waiting six months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 554 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Female |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05608590 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether performing direct tubal flushing with oil-based contrast during hysterosalpingography (HSG) as part of the fertility work-up leads to a 10% increase in ongoing pregnancies and a shorter time to pregnancy compared to delaying the procedure for six months. The study will involve a multicenter randomized controlled trial design, focusing on infertile women aged 18-39 who are at low risk for tubal pathology. Participants will be randomly assigned to receive either immediate or delayed tubal flushing, with an economic analysis to assess cost-effectiveness.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-39 with spontaneous menstrual cycles who are undergoing fertility work-up and are at low risk for tubal pathology.
Not a fit: Patients with known endocrine disorders, ovulation disorders, iodine allergies, or male subfertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to higher pregnancy rates and reduced need for costly fertility treatments.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women between 18-39 years of age * Spontaneous menstrual cycle * Perceived low risk for tubal pathology * Undergoing fertility work-up Exclusion Criteria: * Women with known endocrine disorders (e.g. the polycystic ovary syndrome, diabetes, hyperthyroidism and hyperprolactinemia. Except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l) * Ovulation disorders defined as less than eight menstrual cycles per year * Iodine allergy * Male subfertility defined as a post-wash total motile sperm count \< 1 x10\^6 spermatozoa/ml * Not willing or able to sign the consent form
Where this trial is running
Amsterdam
- Amsterdam AMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: V Mijatovic
- Email: mijatovic@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.