H2Oil-timing: Tubal flushing with oil-based contrast during HSG in subfertile women: Is early flushing effective and costeffective as compared to delayed flushing?
Recruiting
- Conditions
- Subfertility, tubal patency testing
- Registration Number
- NL-OMON23111
- Lead Sponsor
- Amsterdam UMC, VUmc
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 554
Inclusion Criteria
In order to be eligible to participate in this study, women must meet all of the following criteria:
- 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)
- Ovulation disorders defined as less than eight menstrual cycles per year
- Iodine allergy
- Male subfertility defined as a post-wash total motile sperm count < 3 x10^6 spermatozoa/ml
- Not willing or able to sign the consent form
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is time to live birth, calculated from positive pregnancy test and within 12 months after randomization.
- Secondary Outcome Measures
Name Time Method - Live birth<br>- Clinical pregnancy, ongoing pregnancy<br>- Miscarriage, ectopic pregnancy, multiple pregnancy<br>- Complications following HSG (infection, intravasation)<br>- Pregnancy outcomes (f.e. birth weight)<br>- Pregnancy complications<br>- Stillbirth<br>- Thyroid function of the woman (before and 1 month after HSG)<br>- Neonatal outcomes<br>- Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)<br>- Costs within 12 months after randomization<br>- Thyroid function of neonate (determined by heelprick)