Additional tubal flushing with Lipiodol Ultra Fluid after the diagnosis of tubal patency at transvaginal hydrolaparoscopy: a pilot feasibility study in 50 patients.

Completed

Conditions: childless
subfertility
10038612

Registration Number: NL-OMON49816

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

- Age > 18 years
- Subfertility, defined as lack of conception despite 12 months unprotected
intercourse
- Tubal patency of at least one Fallopian tube

Exclusion Criteria

- Pregnancy
- Chlamydia-infection, an acute pelvic inflammation
- Immobile uterus not allowing THL
- Women with a uterus in retroversion flexion, as a THL is not feasible in
these women
- Masses or cysts in the pouch of Douglas or ovarian cysts, interfering with THL
- Iodine allergy
- Allergy for methylene blue or oil containing contrast
- Manifest thyroid dysfunction
- Patients with traumatic injuries, recent major haemorrhage or bleeding (not
including the menstruation)
- The use of the following medicinal products: beta blockers, vasoactive
substances, angiotensin-converting enzyme inhibitors, angiotensin-receptor
blockers, interleukin II (IV route)
- Male subfertility defined as a post-wash total motile sperm count < 3 million
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>The primary objective of this pilot study is to determine the feasibility of<br /><br>additional flushing of the fallopian tubes with Lipiodol Ultra Fluid, in terms<br /><br>of; the appearance of the oil at the tubal fimbriae, the appearance of mucus<br /><br>debris from the tubal fimbriae and the pain and acceptability scores of the<br /><br>patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are the number and nature of adverse events, the<br /><br>influence on the thyroid function of the mother and off-spring, and the amount<br /><br>of oil contrast that is necessary per procedure. The ongoing pregnancy rate,<br /><br>live birth rate and the mode of conception (IVF vs non-IVF) will be compared to<br /><br>the results from a previous study (van Kessel et al., manuscript in progress).</p><br>