To determine the feasibility of additional flushing of the fallopian tubes with Lipiodol after tubal testing with methylene-blue during THL.
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Subfertility is one of life*s great misfortunes. 10-15% of couples seek
specialist fertility care at least once during their reproductive lifetime. The
three most frequent causes of subfertility are sperm defects, ovulation
disorders, and tubal pathology. Over the last decade, transvaginal
hydrolaparoscopy (THL) has been introduced as the method of the first choice
for tubal testing in the fertility workup in four teaching hospitals in the
Netherlands. However, THL denies a possible treatment effect of oil-soluble
contrast media (OSCM). Such a treatment effect after OSCM at
Hysterosalpingography (HSG) has been debated since 1965, until a recent large
randomised controlled trial showed that OSCM at HSG results in higher live
birth rates. Implementation of the use of OSCM (Lipiodol®) is limited as in
many clinics HSG has been replaced by other first line tests for tubal
pathology, including hystero salpingo contrast sonography (HyCoSy/HyFoSy) and
THL. The therapeutic effect of additional tubal flushing with Lipiodol® after
tests such as THL is however still unclear.
Study objective
To determine the feasibility of additional flushing of the fallopian tubes with
Lipiodol after tubal testing with methylene-blue during THL.
Study design
Single-centre clinical pilot study, at the Máxima Medical Center in the
Netherlands.
Intervention
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).
Study burden and risks
Since Lipiodol has already been used at HSG, we do not expect additional risks
or burdens from the study.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67021.015.19 |
| OMON | NL-OMON29484 |