Infertile
women undergoing Hysterosalpingography (HSG) with an oil based contrast have a
10% higher chances of getting pregnant and continue the pregnancy as compared
to women who have HSG with a water based medium reports results of a multicentric,
randomized trial from Netherlands.
The
study was published online May 18 in the New England Journal of Medicine and
presented at the 13th World Congress on Endometriosis in Vancouver, Canada.
Looking
back, the debate about superiority of one medium over other has been going on for
50 years. It is known that flushing of the fallopian tube enhances fertility,
but controversy about the type of medium continues.
First HSG
was carried out by Carey in 1914 and he used collergol. Lipiodol was introduced
by Sicard and Forestier in 1924 and remained a popular contrast medium for many
decades. Later, water-soluble contrast material was generally preferred as it
avoided the possible complication of oil embolism.
A 2007
update of Cochrane review concluded that “Flushing of the tubes with
oil-soluble media increases subsequent pregnancy rates in infertility patients. Clinicians should consider flushing the tubes with
OSCM before contemplating more invasive therapies.”
While
other smaller studies have reported that contrast does not affect the cumulative
pregnancy rate.
The
current study called the The H2Oil study was conducted by Professor Ben W.J. Mol
along with Dr. Kim Dreyer & Dr. Velja Mijatovic from the Department of
Reproductive Medicine, VU University Medical Centre, Amsterdam, and their
multi-center research team from 27 hospitals in the Netherlands.
The study recruited 1,119 women who
were undergoing fertility treatment and were advised hysterosalpingography
(HSG). The women were randomized to a standard HSG with water-soluble contrast
medium (WSCM)(Hystero) or another group which used an oil-based contrast with
Lipiodol Ultra-Fluide. (LIPIODOL Ultra-Fluid 480 Injection 10 mL, GUERBET). (Ethiodol
in the United States). Then couples received expectant management or the women
underwent intrauterine insemination.
All women were between 18 and 39 years
of age, with regular menstrual cycles, and were undergoing treatment for infertility
for at least 1 year.
The primary outcome measure was positive
fetal heart rate by USG at 12 weeks of pregnancy within 6 months of the HSG
test. Multiple secondary outcomes were tested like positive pregnancy test by
USG, live birth, ectopic pregnancy, miscarriage and pain scores by the
Visual-Analogue Scale for Pain.
After statistical analysis at 6
months, it was seen that 220(39.7%) in oil-based group had an ongoing pregnancy
versus 161(29.1%) in water based group (P <.001). The oil based group also
had considerable more live birth rates, 38.8% versus 28.1% (P <.001).
Professor Mol said “This means that
for every ten women undergoing an HSG to test their fallopian tubes, if
Lipiodol® is used for that test, there will be one more pregnancy six months
later and, consequently, one more baby nine months after that.”
The groups were comparable to each
other in terms of bilateral tubal patency, pain score, miscarriage rates, ectopic
pregnancy, twins, stillbirth rates and median duration of pregnancy.
“If we move to the use of Lipiodol®
Ultra-Fluid for routine diagnostic tubal patency testing, more women will have
a successful fertility outcome and will avoid the need for other expensive
fertility treatments such as IVF. I believe that is justifiable at this point,”
he further added.
Professor Mol has a personal
connection with the study which came to light only when he started researching
about HSG. He himself was born, after his mother underwent HSG using Lipiodol
after being infertile for 9 years.
Professor Neil Johnson, President of
the World Endometriosis Society concluded “This new study from our Dutch
colleagues confirms beyond doubt the fertility value of Lipiodol® Ultra-Fluid.”
