Additional tubal flushing with Lipiodol Ultra fluid after the diagnosis of tubal patency at transvaginal hydrolaparoscopy: a pilot feasibility study in 50 patients
- Conditions
- <p>50 subfertile women who showed tubal patency of at least one tube at THL.</p>10033283
- Registration Number
- NL-OMON29484
- Lead Sponsor
- Board of Management Máxima MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
- Age > 18 years - Subfertility, defined as lack of conception despite 12 months of unprotected intercourse - Tubal patency of at least one Fallopian tube
- Pregnancy - Chlamydia-infection, an acute pelvic inflammation - Immobile uterus not allowing THL - Women with an 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 additional flushing of the fallopian tubes with Lipiodol Ultra Fluid, in terms of; the appearance of the oil at the tubal fimbriae, the appearance of mucus debris from the tubal fimbriae and the pain and acceptability scores of the patients.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are the number and nature of adverse events, the influence on the thyroid function of the mother and the off-spring, and the amount of oil contrast that is necessary per procedure. The ongoing pregnancy rate, live birth rate and the mode of conception (IVF vs non-IVF) will be compared to the results from a previous study (van Kessel et al.).</p><br>
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