Oil- based versus water-based contrast media for hysterosalpingography (HSG) in women with an unfulfilled childwish with ovulation disorders, at high risk for tubal pathology or above 38 years of age.
- Conditions
- The research population consists of infertile couples who have tried to conceive for at least 12 months, or have oligo- or anovulation. We will focus on women with ovulation disorders, or at high risk for tubal pathology or above 38 years of age.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2018-004192-12-NL
- Lead Sponsor
- Amsterdam UMC, location VU medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 930
In order to be eligible to participate in this study, a 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: above 38 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 930
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
- Endocrine disorders as diabetes, hyperthyroidism or hyperprolactinemia (except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method