Tubal flushing with oil-based contrast during HSG in subfertile women: Is early flushing effective and cost-effective as compared to delayed flushing?

Recruiting

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

Registration Number: NL-OMON52895

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 354

Inclusion Criteria

- Women between 18-39 years of age
- Spontaneous menstrual cycle
- Perceived low risk for tubal pathology
- Undergoing fertility work-up with an indication for tubal patency testing

Exclusion Criteria

- Women with known endocrine disorders (e.g. the polycystic ovary syndrome,
diabetes, hyperthyroidism and hyperprolactinemia, except for well managed
hypothyroidism (TSH 0.3-2.5mIU/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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is time to life birth within 6 and 12 months after<br /><br>randomization. Time to live birth within 6 months after randomization provides<br /><br>us information about the comparison on HSG with oil-based contrast performed<br /><br>during fertility work-up compared to no HSG. Time to live birth within 12<br /><br>months after randomization provides information on the comparison of HSG with<br /><br>oil-based contract during fertility work-up versus 6 months after completing<br /><br>fertility work-up. Our hypothesis is that tubal flushing at HSG with oil-based<br /><br>contrast incorporated in the fertility work-up will result in 10% more ongoing<br /><br>pregnancies and a shorter time to pregnancy, and thus reducing the need for ART<br /><br>and reducing costs.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Life birth<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>- Direct and indirect costs within 12 months after randomization<br /><br>- Thyroid function of neonate (determined by heelprick by RIVM)<br /><br>- Level of pain and anxiety during HSG</p><br>