European Journal of Obstetrics & Gynecology and Reproductive Biology 163 (2012) 6266

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European Journal of Obstetrics & Gynecology and

Reproductive Biology
journal homepage: www.elsevier.com/locate/ejogrb

Selective salpingography: preliminary experience of an ofce operative option for

proximal tubal recanalization
Luigi Cobellis a,*, Francesco Argano b, Maria Antonietta Castaldi a, Gennaro Acone a, Daniela Mele a,
Giuseppe Signoriello c, Nicola Colacurci a
a
b
c

Department of Gynaecology, Obstetric and Reproductive Science, Second University of Studies of Naples, Naples, Italy
Operative Unit of Radiodiagnostic, P.O.S.M.d P. Incurabili, Naples, Italy
Department of Public Medicine, Section of Statistics, Second University of Naples, Naples, Italy

A R T I C L E I N F O

A B S T R A C T

Article history:
Received 3 September 2011
Received in revised form 8 March 2012
Accepted 29 March 2012

Objective: To evaluate treatment efcacy and patient acceptability of the new Radiographic Tubal
Assessment Set (RTAS) (Cook Ireland Ltd., Limerick, Ireland) for selective salpingography (SSG).
Study design: 33 women, between 23 and 38 years old, referred to the Fertility Centre of the Department
of Obstetrics, Gynecology and Reproductive Science, Second University of Naples, for sterility problems,
underwent an ofce operative SSG with the RTAS. Of the 33 women, 12 had bilateral tubal obstruction
(Group A) and 21 had unilateral tubal obstruction (Group B). Patients who did not regain tubal patency
were referred for laparoscopic surgery. To verify patient acceptability, a visual analogue score (VAS 1-10)
of pain was completed immediately after the procedure.
Results: From a total of 45 obstructed fallopian tubes, 34 were recanalized, giving a success rate for the
procedure of 75.6% (p < 0.001). Nine patients with bilateral tubal obstruction (Group A) had the tubes
recanalized and ve obtained a spontaneous pregnancy. Sixteen patients with monolateral tubal
obstruction (Group B) had the tubes recanalized and nine obtained a spontaneous pregnancy. A total of
seven patients were sent for operative laparoscopy: four of them had the tubes recanalized and two
obtained a spontaneous pregnancy. One patient was lost to follow-up. The evaluation of the level of pain
felt during the procedure on the 10 cm VAS showed mean pelvic pain 2.9  2.2, and an incidence of no
discomfort  low pain signicantly higher than moderate  severe pain (p < 0.0001).
Conclusion: The RTAS can be considered a safe and effective tool to perform this ofce operative
procedure for tubal recanalization, with a high acceptability for the patient. The see and treat approach
in patients with proximal tubal obstruction (PTO) suggests for the future the use of this device under
sonographic guidance, taking into account accurate patient selection.
2012 Elsevier Ireland Ltd. All rights reserved.

Keywords:
Selective salpingography
Proximal tubal obstruction
Fertility
Pelvic pain

1. Introduction
Tubal disease is the cause of subfertility in approximately 30%
of women, and 1025% of these cases are due to proximal tubal
obstruction (PTO) [1]. In the past hysterosalpingography (HSG) has
represented the most accurate diagnostic tool to obtain information about both the uterine cavity and tubal patency. A high
incidence of false-positive diagnosis of PTO (ranging from 16% to
40%) is reported, with no correlation between radiological and
pathological ndings in approximately two-thirds of the Fallopian
tubes resected [2,3]. Moreover, Woolcott has reported that when

* Corresponding author at: Department of Gynaecology, Obstetric and Reproductive Science, Second University of Studies of Naples, Largo Madonna delle Grazie
1, 80138 Naples, Italy. Tel.: +39 0815665608; fax: +39 0815665608.
E-mail address: luigi.cobellis@unina2.it (L. Cobellis).
0301-2115/$ see front matter 2012 Elsevier Ireland Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ejogrb.2012.03.037

bilateral proximal blockage was diagnosed by both HSG and

laparoscopy, about 35% of tubes showed patency at selective
salpingography [4].
In the last 10 years selective tubal catheterization has been
evaluated as an option in patients with hysterosalpingographic
ndings of PTO [5]. In fact since 1993 the American Society for
Reproductive Medicine has recommended that patients who have
PTO undergo selective salpingography (SSG) and tubal recanalization before considering the more invasive and costly treatments [6].
SSG, a procedure in which the fallopian tube is directly opacied
through a catheter placed in the tubal ostium, has been used since
the late 1980s [7]. Since the rst descriptions, there have been
numerous reports of successful cannulation using different devices
(ureteral stents or catheters, epidural catheters, guidewires, etc.) [8
10]. The key point is to obtain, if possible, an accurate distinction
between true pathologic occlusion, spasm or mucosa abnormalities,
crucial to determining therapy and further infertility approach [8].

L. Cobellis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 163 (2012) 6266

The indications for, and limitations of, Fallopian tube recanalization

require an accurate and exhaustive evaluation of the tube, because
PTO is a not a standardized condition, and there are differences in the
pathogenesis and between patients [11,12].
The aim of this study is to evaluate and report the preliminary
results of the feasibility, treatment efcacy and patient acceptability of the new Radiographic Tubal Assessment Set (RTAS) (Cook
Ireland Ltd., Limerick, Ireland) for SSG.
2. Materials and methods
The study involved 33 infertile women (age range 2338 years),
referred to the Fertility Centre of the Department of Obstetrics,
Gynecology and Reproductive Science of the Second University of
Naples. All patients were enrolled with a previous hysterosalpingographic diagnosis of PTO, monolateral or bilateral. All of them
gave informed consent at study inclusion.
The study protocol, informed consent, and test product(s)
information received institutional review board (IRB) approval
before the beginning of the study, in accordance with The Code of
Ethics of the Declaration of Helsinki.
The characteristic of the patients is depicted in Table 1. All the
patients received a careful evaluation, in order to achieve an
optimal and complete fertility assessment. Of the 33 women, 12
had bilateral tubal obstruction (Group A); 21 had monolateral
proximal tubal obstruction (Group B). All the patients were sent for
an ofce SSG with the RTAS (Fig. 1).
The procedure was performed in the proliferative menstrual
phase, which facilitates better image interpretation. The patients
were asked to refrain from unprotected sexual intercourse from
the date of her period until after the investigation to be certain
there is no risk of pregnancy.
SSG with the RTAS was performed with the following
procedure. The patient was placed on the uoroscopic machine
in a gynaecologic examination position. After the external genital
area had been cleaned with antiseptic solution, the vagina was
dilated by a gynaecologic dilator. The cervix was localized and
cleansed with iodine solution. Next, the external cervical ostium
was catheterized. The catheter was pushed through the vagina and
the cervix to the uterine cavity, and the balloon was inated. The
vaginal dilator was removed after catheterization and before

63

Table 1
Demographics, success at cannulation and pregnancy outcomes of the 33 women
recruited at Second University of Naples.
Parameter

Value

Mean age in years (range)

Bilateral block (Group A)
Both successfully cannulated
One tube successfully cannulated
Neither side cannulated
Unilateral block (Group B)
Tube successfully cannulated
Success rate
Per tube cannulated
Per patient
Pregnancy outcomesa
Live birth
Ectopic pregnancy
Miscarriage
Unknown
Failed to conceive
Other fertility treatment
Ovulation induction
Intrauterine insemination
IVF
Outcome information missing

27 (2338)
12/33 (36.4%)
8/12 (66.6%)
2/12 (16.7%)
2/12 (16.7%)
21/33 (64.6%)
16/33 (48.9%)

34/45 (75.6%)
25/33 (75.7%)
16/33 (48.5%)
15/16 (93.8%)
0 (0%)
1/16 (6.2%)
1/33 (3.0%)
17/33 (51.5%)
5
2
3
1/33 (3.0%)

After a 6 month follow-up.

administration of the contrast medium. Instillation of 510 ml of a

water-soluble contrast agent into uterus let us perform standard
hysterosalpingography. At this point, after verifying the presence
of a tubal obstruction (Fig. 2a) the SSG Catheter was introduced
through the working channel of the Intrauterine Access Balloon
Catheter until the SSG Catheter marker ink enters the Check Flo
Adapter located on the proximal end of the Intrauterine Access
Balloon. While scanning with uoroscopy, the catheter was rotated
to address the appropriate fallopian tube. Since the distal tip of the
SSG Catheter was radiopaque, it was visible under uoroscopy
(Fig. 2b). An appropriate quantity of contrast medium was injected
through the SSG Catheter to better dene tubal patency and
perform tubal recanalization. If the obstruction was overcome the
tubal contour was outlined with contrast (Fig. 2c). If it persisted, a
guide-wire was threaded through the inner cannula and was
advanced towards the obstruction. A gentle push was applied to

Fig. 1. The Radiographic Tubal Assessment Set (RTAS): (A) catheter used for standard HSG with operative channel, where the (B) Selective Salpingography (SSG) Catheter
passes through.

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L. Cobellis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 163 (2012) 6266

Fig. 2. (A) Bilateral proximal tubal obstruction. (B) The distal tip of the SSG Catheter is radiopaque and clearly visible under uoroscopy. (C) Bilateral tubal recanalization
obtained after the injection of appropriate quantity of contrast medium through the SSG Catheter.

overcome it. The guide-wire was then withdrawn and contrast

medium was injected through the SSG Catheter to conrm
patency.
To verify patient acceptability, a visual analogue score of pain
was performed immediately after the procedure [13]. Patients
were asked to complete privately an anonymous questionnaire
assessing the maximum amount of pain suffered during the
procedure, by making a cross on a 10 cm visual analogue scale
(VAS). The following classication was used: 01 = no discomfort;
24 = discomfort similar to normal menstrual pain; 57 = moderate pain similar to heavy menstrual pain; 810 = several pain. Two
groups were then created (no pain + low pain, and medium
pain + severe pain) and the difference tested by using Students ttest for unpaired samples. Statistical signicance was set at
p < 0.05.
Data distribution was assessed with the ShapiroWilk test, and
Fishers exact test for non-parametric comparisons was used for
statistical analysis. Statistical signicance was set at p < 0.05.
3. Results
The study includes 33 patients undergoing ofce operative SSG
with the RTAS. The mean time for the whole procedure was 19 min
(range 1527). The mean uoroscopy time was 51.2 s (range 48.2
116.5), and the mean estimated surface dose was 32 mGy (range
1246), while the equivalent dose to the ovaries was 0.98 mSv
(range 0.451.35).
Complete tubal recanalization during the procedure was
performed in 9 of the 12 patients in Group A (bilateral), and in
16 of the 21 patients in Group B (unilateral). Seven patients in

whom we failed to achieve tubal recanalization were sent for

laparoscopy. One patient in Group B was lost to follow-up. Of a
total of 45 obstructed fallopian tubes, 34 were recanalized, with a
success rate for the procedure of 75.6% (p < 0.001) (Fig. 3).
After a 6-month follow-up the overall pregnancy rate for the
successful SSG procedure was 56%, while for SSG + laparoscopy it
was 42.9%. There was no statistical difference in tubal recanalization rates or in pregnancy rates between SSG and SSG + laparoscopy: the exact p was 0.126 for tubal recanalization and 0.279 for
pregnancy rate on the Fischer exact test (Table 2).
The evaluation of the level of pain the patient had felt during the
procedure on the 10 cm VAS gave some very signicant results: the
level of pelvic pain, rated according to the four classes of the VAS
(severe 8  10, moderate 5  7, low 2  4, no pain 0  1), showed
mean pelvic pain 2.9  2.2, and an incidence of no discomfort  low
pain signicantly higher than moderate  severe pain (p < 0.0001).
The results of the VAS assessment of patient discomfort are reported
in Fig. 4.
No failures or major complications (i.e. severe pain, vagal reex,
intravasation, uterine perforation, etc.) occurred during the
procedures, and none of the patients developed infection or
allergic reaction against the contrast media after the procedure.
4. Comment
The Royal College of Obstetricians and Gynaecologists guidelines
and the National Institute for Health and Clinical Excellence (NICE)
guidelines dene HSG screening for tubal occlusion as part of the
initial assessment of infertility [11,12,14]. Infertility affects approximately one in six couples during their lifetime [14]. Each gynecologist
can expect to see on average 30300 or more infertile couples each
year, and will investigate them with appropriate tests [15].
During the past 15 years, SSG has been rarely used as an option
in patients with hysterosalpingographic ndings of PTO [5].

Table 2
Patients recanalized and number of spontaneous pregnancy obtained at SSG and
SSG + laparoscopy in Group A (bilateral tubal obstruction) and Group B (monolateral
tubal obstruction).

Group A
Group B
Total
Fig. 3. The SSG performed with the Radiographic Tubal Assessment Set (RTAS),
obtained a rate of successful procedure of the 75.6% (p < 0.001).

No. of
patients

No. of patients
recanalized with
SSG (recanalized
tubes)/No. of
spontaneous
pregnancy obtained

No. of patients
recanalized with
laparoscopy + SSG
(recanalized tubes)
/No. of spontaneous
pregnancy obtained

p valuea

12
20
32

9 (18)/5
16 (16)/9
25 (34)/14

3 (5)/1
4 (8)/2
7 (13)/3

NS
NS
NS

a
Fishers exact test.
One patient of Group B was lost at follow-up and thus not included in the table.

L. Cobellis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 163 (2012) 6266

65

Fig. 4. Patients acceptability during ofce operative SSG with the Radiographic Tubal Assessment Set (RTAS): incidence of no discomfort  low pain resulted signicantly
lower than moderate  severe pain (p < 0.0001).

Indeed, this procedure was introduced in the late 1980s as a

diagnostic procedure in which the fallopian tube is directly
opacied through a catheter placed in the tubal ostium, thus
helping to differentiate spasm from true obstruction and to clarify
discrepant ndings from other tests. SSG is a transvaginal
outpatient procedure, recommended specically for the diagnosis
and treatment of proximal tubal blockage [10]. Therefore operative
recanalization, where a catheter and guide wire system is used to
clear PTO is rarely performed and only by trained interventional
radiologists and successfully completed in most patients (7192%)
[5].
Proximal Fallopian tube obstruction is the main indication for
this procedure [11,12,14]. This is due to practical considerations
and also because the anatomical position in the abdomen make the
distal Fallopian tube an organ which is often involved in different
comorbidities (such as pelvic inammatory disease, previous
ectopic pregnancy or endometriosis) [12,16].
Pregnancy rates after the procedure have been variable, with an
average rate of 30% (2265%) [5,16]. The same catheterization
technique used in fallopian tube recanalization is currently being
explored for use in tubal sterilization [16].
In the present study we evaluated treatment efcacy and
patient acceptability of the new RTAS for an ofce operative SSG in
order to recanalize fallopian tube obstruction. In all cases who had
a previous hysterosalpingographic diagnosis of tubal obstruction,
we performed a standard HSG and an operative disobstruction by
direct insufation of the contrast medium in the tubal lumen. In
this way we obtained recanalization in 75.6% of the cases. This
technique offers several advantages in terms of procedural
elements and patient security.
In particular, the RTAS improves the possibility of reducing the
in utero insufation pressure, as a consequence of a selective
action on the tubal lumen, avoiding either in utero pressure
dispersal or spread to the contralateral tube. Additionally, the
application of the guide-wire, whose effectiveness in achieving
tubal recanalization was proven in previous studies [1720],
turned out to be a successful integral part of the present method of
SSG. Furthermore, nowadays, the use of a water-soluble contrast
medium lowers the risk of lymphatic or vascular intravasation,
which can be clinically signicant and dangerous [17].

Moreover we evaluated patient acceptability of SSG with the

RTAS. The overall compliance with the technique was really high
with 69.7% of the women experiencing no pain or low pain. The
advantage of using this ofce operative technique is self-evident if
we consider the patients compliance: in most examinations only
slight pain or a feeling of discomfort during or at the end of the
examination (mean pelvic pain 2.9  2.2 in the 010 VAS) was
reported, which is comparable to the level of pain felt during
transvaginal ultrasound. Sometimes the worst discomfort was linked
only to the introduction or withdrawal of the speculum.
Therefore, the RTAS can be considered a safe and effective tool
to perform this ofce operative procedure for tubal recanalization,
with high acceptability for the patient.
Additionally, as we performed a standard HSG before each
operative procedure, we suggest the use of the RTAS to perform a
one-step diagnostic and operative procedure, with the clear
advantage of reducing operative time and patient radiation
exposure. Indeed, this technique let us perform an operative
recanalization in an ofce setting, right after a diagnosis of tubal
obstruction is made. Moreover, this method exposes the patient to
a single radiation dose, rather than submit her to a second SSG. A
recent paper showed that the radiation dose delivered in a single
procedure unifying HSG and tube recanalization was signicantly
different than using two consecutive HSGs, and the latter method
showed a signicantly lower pregnancy rate [21].
Indeed, potential adverse health effects associated with radiation
exposure are an important factor to consider when selecting patients
for repeated radiologic procedures [8,9]. Therefore changes in
standard HSG protocols intended to limit the number of exposures,
such as elimination of the routine oblique and lateral radiographic
projections, and the use of digital uoroscopy for HSG have reduced
radiation exposure [9,22,23]. Besides, the radiation dose to the
ovaries from the present procedure is approximately 1 mSv, a dose
that is within accepted limits for women of reproductive age, as
recommended in the recent American College of Radiology white
paper on radiation dose in medicine [24].
Although the fertilized gamete is radiosensitive, the ovum before
fertilization is relatively radioresistant. Selective salpingography
with fallopian tube recanalization is performed in the follicular
phase of the ovulatory cycle to ensure that the patient is not

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pregnant and to minimize potential biological damage [10].

Moreover, as in our study we achieved a 75.6% rate of tubal
recanalization, only seven patients were sent for laparoscopy, which
requires anesthesia, and has higher costs, being a surgical technique
[5,25].
These preliminary results showed that the RTAS can be
considered a safe and effective tool to perform this ofce operative
procedure for tubal recanalization, with high acceptability for the
patient. Further studies are in progress in order to replicate and
extend these ndings. Actually a larger number of patients are in
course of enrolment to gain strong conclusions and to dene a
possible role of SSG not only for the treatment of proximal tubal
obstruction, but also for other types of fallopian blockage, such as
isthmic portion obstruction.
Indeed, since the results of a recent meta-analysis showed that
patient characteristics, such as female age, duration of subfertility
and BMI, were not associated with the accuracy of HSG [26], a onestep diagnostic and operative procedure in an ofce setting should
be an optimal solution for all infertile patients as well. Finally, we
suggest that a possibility for the future is the implementation of a
similar ofce operative approach by using the RTAS under
sonographic guidance.
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