H2Oil2: Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial
Recruiting
- Conditions
- Subfertility, tubal patency testing
- Registration Number
- NL-OMON24142
- Lead Sponsor
- Amsterdam UMC, VUmc
- Brief Summary
/ A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 930
Inclusion Criteria
In order to be eligible to participate in this study, women must meet one of the following criteria:
1: with ovulation disorders (ovulation disorders will be defined as less than 8 menstrual cycles per year) or;
2: at high risk for tubal pathology (high risk for tubal pathology will be defined as a positive chlamydia infection, a pelvic inflammatory disease, known endometriosis, abdominal surgery (including tubectomy for ectopic pregnancy and appendectomy) and/or peritonitis in the medical history) or;
3: 39 years of age or over
Exclusion Criteria
- Iodinated contrast agent allergy
- Male subfertility defined as 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 Conception leading to live birth with a positive pregnancy test within 6 months after randomization.
- Secondary Outcome Measures
Name Time Method - Biochemical pregnancy, clinical pregnancy, ongoin pregnancy<br>- Miscarriage, ectopic pregnancy, multiple pregnancy<br>- Time to pregnancy<br>- Complications following HSG (infection, intravastion)<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 6 months after randomization<br>- Thyroid function of neonate (determined by heelprick)