childless subfertility
Conditions
Interventions
After tubal patency has been established with the installation of
methylene-blue during the THL, women will undergo additional flushing of the
fallopian tubes with Lipiodol (max 10mL).
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are the number and nature of adverse events, the influence on the thyroid function of the mother and 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., manuscript in progress). | — |
Countries
Netherlands
Outcome results
None listed