Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial

Phase 4

Recruiting

Conditions: testing if the fallopian tubes are open
Tubal patency testing
10033283

Registration Number: NL-OMON52387

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 680

Inclusion Criteria

Women:
1: with ovulation disorders (defined as less than 8 menstrual cycles per year)
or;
2: at high risk for tubal pathology (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

Exclusion Criteria

- Iodine allergy
- Male subfertility defined as a post-wash total motile sperm count < 1 x106
spermatozoa/ml
- Not willing or able to sign the consent form
- Endocrine disorder as diabetes, hyperthyroidism or hyperprolactinaemia except
for well managed hypothyroidism (TSH between 0.3 and 2.5mIU/l)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is conception leading to live birth within 6 months after<br /><br>randomization.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Biochemical pregnancy<br /><br>- Clinical pregnancy<br /><br>- Ongoing pregnancy<br /><br>- Miscarriage<br /><br>- Ectopic pregnancy<br /><br>- Multiple pregnancy<br /><br>- Complications following HSG (infection, intravastion)<br /><br>- Pregnancy outcomes (f.e. birth weight)<br /><br>- Pregnancy complications<br /><br>- Stillbirth<br /><br>- Thyroid function of the woman (before and 1 month after HSG)<br /><br>- Neonatal outcomes<br /><br>- Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)<br /><br>- Costs within 6 months after randomization<br /><br>- Thyroid function of neonate (determined by heelprick)</p><br>