European Journal of Obstetrics & Gynecology and Reproductive Biology 163 (2012) 62–66

Selective salpingography: preliminary experience of an office operative option forproximal 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 Department of Gynaecology, Obstetric and Reproductive Science, Second University of Studies of Naples, Naples, Italyb Operative Unit of Radiodiagnostic, P.O.S.M.d P. Incurabili, Naples, Italyc Department of Public Medicine, Section of Statistics, Second University of Naples, Naples, Italy

A R T I C L E I N F O

Article history:

Received 3 September 2011

Received in revised form 8 March 2012

Accepted 29 March 2012

Keywords:

Selective salpingography

Proximal tubal obstruction

Fertility

Pelvic pain

A B S T R A C T

Objective: To evaluate treatment efficacy 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 office 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 five 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 significantly higher than moderate � severe pain (p < 0.0001).

Conclusion: The RTAS can be considered a safe and effective tool to perform this office 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.

Contents lists available at SciVerse ScienceDirect

European Journal of Obstetrics & Gynecology andReproductive Biology

jou r nal h o mep ag e: w ww .e lsev ier . co m / loc ate /e jo g rb

1. Introduction

Tubal disease is the cause of subfertility in approximately 30%of women, and 10–25% of these cases are due to proximal tubalobstruction (PTO) [1]. In the past hysterosalpingography (HSG) hasrepresented the most accurate diagnostic tool to obtain informa-tion about both the uterine cavity and tubal patency. A highincidence of false-positive diagnosis of PTO (ranging from 16% to40%) is reported, with no correlation between radiological andpathological findings in approximately two-thirds of the Fallopiantubes resected [2,3]. Moreover, Woolcott has reported that when

* Corresponding author at: Department of Gynaecology, Obstetric and Repro-

ductive 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 andlaparoscopy, about 35% of tubes showed patency at selectivesalpingography [4].

In the last 10 years selective tubal catheterization has beenevaluated as an option in patients with hysterosalpingographicfindings of PTO [5]. In fact since 1993 the American Society forReproductive Medicine has recommended that patients who havePTO undergo selective salpingography (SSG) and tubal recanaliza-tion before considering the more invasive and costly treatments [6].

SSG, a procedure in which the fallopian tube is directly opacifiedthrough a catheter placed in the tubal ostium, has been used sincethe late 1980s [7]. Since the first descriptions, there have beennumerous 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 distinctionbetween true pathologic occlusion, spasm or mucosa abnormalities,crucial to determining therapy and further infertility approach [8].

Table 1Demographics, success at cannulation and pregnancy outcomes of the 33 women

recruited at Second University of Naples.

Parameter Value

Mean age in years (range) 27 (23–38)

Bilateral block (Group A) 12/33 (36.4%)

Both successfully cannulated 8/12 (66.6%)

One tube successfully cannulated 2/12 (16.7%)

Neither side cannulated 2/12 (16.7%)

Unilateral block (Group B) 21/33 (64.6%)

Tube successfully cannulated 16/33 (48.9%)

Success rate

Per tube cannulated 34/45 (75.6%)

Per patient 25/33 (75.7%)

Pregnancy outcomesa 16/33 (48.5%)

Live birth 15/16 (93.8%)

Ectopic pregnancy 0 (0%)

Miscarriage 1/16 (6.2%)

Unknown 1/33 (3.0%)

Failed to conceive 17/33 (51.5%)

Other fertility treatment

Ovulation induction 5

Intrauterine insemination 2

IVF 3

Outcome information missing 1/33 (3.0%)

a After a 6 month follow-up.

L. Cobellis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 163 (2012) 62–66 63

The indications for, and limitations of, Fallopian tube recanalizationrequire an accurate and exhaustive evaluation of the tube, becausePTO is a not a standardized condition, and there are differences in thepathogenesis and between patients [11,12].

The aim of this study is to evaluate and report the preliminaryresults of the feasibility, treatment efficacy and patient acceptabil-ity of the new Radiographic Tubal Assessment Set (RTAS) (CookIreland Ltd., Limerick, Ireland) for SSG.

2. Materials and methods

The study involved 33 infertile women (age range 23–38 years),referred to the Fertility Centre of the Department of Obstetrics,Gynecology and Reproductive Science of the Second University ofNaples. All patients were enrolled with a previous hysterosalpin-gographic diagnosis of PTO, monolateral or bilateral. All of themgave informed consent at study inclusion.

The study protocol, informed consent, and test product(s)information received institutional review board (IRB) approvalbefore the beginning of the study, in accordance with The Code ofEthics of the Declaration of Helsinki.

The characteristic of the patients is depicted in Table 1. All thepatients received a careful evaluation, in order to achieve anoptimal and complete fertility assessment. Of the 33 women, 12had bilateral tubal obstruction (Group A); 21 had monolateralproximal tubal obstruction (Group B). All the patients were sent foran office SSG with the RTAS (Fig. 1).

The procedure was performed in the proliferative menstrualphase, which facilitates better image interpretation. The patientswere asked to refrain from unprotected sexual intercourse fromthe date of her period until after the investigation to be certainthere is no risk of pregnancy.

SSG with the RTAS was performed with the followingprocedure. The patient was placed on the fluoroscopic machinein a gynaecologic examination position. After the external genitalarea had been cleaned with antiseptic solution, the vagina wasdilated by a gynaecologic dilator. The cervix was localized andcleansed with iodine solution. Next, the external cervical ostiumwas catheterized. The catheter was pushed through the vagina andthe cervix to the uterine cavity, and the balloon was inflated. Thevaginal dilator was removed after catheterization and before

Fig. 1. The Radiographic Tubal Assessment Set (RTAS): (A) catheter used for standard H

passes through.

administration of the contrast medium. Instillation of 5–10 ml of awater-soluble contrast agent into uterus let us perform standardhysterosalpingography. At this point, after verifying the presenceof a tubal obstruction (Fig. 2a) the SSG Catheter was introducedthrough the working channel of the Intrauterine Access BalloonCatheter until the SSG Catheter marker ink enters the Check FloAdapter located on the proximal end of the Intrauterine AccessBalloon. While scanning with fluoroscopy, the catheter was rotatedto address the appropriate fallopian tube. Since the distal tip of theSSG Catheter was radiopaque, it was visible under fluoroscopy(Fig. 2b). An appropriate quantity of contrast medium was injectedthrough the SSG Catheter to better define tubal patency andperform tubal recanalization. If the obstruction was overcome thetubal contour was outlined with contrast (Fig. 2c). If it persisted, aguide-wire was threaded through the inner cannula and wasadvanced towards the obstruction. A gentle push was applied to

SG with operative channel, where the (B) Selective Salpingography (SSG) Catheter

Fig. 2. (A) Bilateral proximal tubal obstruction. (B) The distal tip of the SSG Catheter is radiopaque and clearly visible under fluoroscopy. (C) Bilateral tubal recanalization

obtained after the injection of appropriate quantity of contrast medium through the SSG Catheter.

L. Cobellis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 163 (2012) 62–6664

overcome it. The guide-wire was then withdrawn and contrastmedium was injected through the SSG Catheter to confirmpatency.

To verify patient acceptability, a visual analogue score of painwas performed immediately after the procedure [13]. Patientswere asked to complete privately an anonymous questionnaireassessing the maximum amount of pain suffered during theprocedure, by making a cross on a 10 cm visual analogue scale(VAS). The following classification was used: 0–1 = no discomfort;2–4 = discomfort similar to normal menstrual pain; 5–7 = moder-ate pain similar to heavy menstrual pain; 8–10 = several pain. Twogroups were then created (no pain + low pain, and mediumpain + severe pain) and the difference tested by using Student’s t-test for unpaired samples. Statistical significance was set atp < 0.05.

Data distribution was assessed with the Shapiro–Wilk test, andFisher’s exact test for non-parametric comparisons was used forstatistical analysis. Statistical significance was set at p < 0.05.

3. Results

The study includes 33 patients undergoing office operative SSGwith the RTAS. The mean time for the whole procedure was 19 min(range 15–27). The mean fluoroscopy time was 51.2 s (range 48.2–116.5), and the mean estimated surface dose was 32 mGy (range12–46), while the equivalent dose to the ovaries was 0.98 mSv(range 0.45–1.35).

Complete tubal recanalization during the procedure wasperformed in 9 of the 12 patients in Group A (bilateral), and in16 of the 21 patients in Group B (unilateral). Seven patients in

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).

whom we failed to achieve tubal recanalization were sent forlaparoscopy. One patient in Group B was lost to follow-up. Of atotal of 45 obstructed fallopian tubes, 34 were recanalized, with asuccess rate for the procedure of 75.6% (p < 0.001) (Fig. 3).

After a 6-month follow-up the overall pregnancy rate for thesuccessful SSG procedure was 56%, while for SSG + laparoscopy itwas 42.9%. There was no statistical difference in tubal recanaliza-tion rates or in pregnancy rates between SSG and SSG + laparo-scopy: the exact p was 0.126 for tubal recanalization and 0.279 forpregnancy rate on the Fischer exact test (Table 2).

The evaluation of the level of pain the patient had felt during theprocedure on the 10 cm VAS gave some very significant results: thelevel 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), showedmean pelvic pain 2.9 � 2.2, and an incidence of no discomfort � lowpain significantly higher than moderate � severe pain (p < 0.0001).The results of the VAS assessment of patient discomfort are reportedin Fig. 4.

No failures or major complications (i.e. severe pain, vagal reflex,intravasation, uterine perforation, etc.) occurred during theprocedures, and none of the patients developed infection orallergic reaction against the contrast media after the procedure.

4. Comment

The Royal College of Obstetricians and Gynaecologists’ guidelinesand the National Institute for Health and Clinical Excellence (NICE)guidelines define HSG screening for tubal occlusion as part of theinitial assessment of infertility [11,12,14]. Infertility affects approxi-mately one in six couples during their lifetime [14]. Each gynecologistcan expect to see on average 30–300 or more infertile couples eachyear, and will investigate them with appropriate tests [15].

During the past 15 years, SSG has been rarely used as an optionin patients with hysterosalpingographic findings of PTO [5].

Table 2Patients recanalized and number of spontaneous pregnancy obtained at SSG and

SSG + laparoscopy in Group A (bilateral tubal obstruction) and Group B (monolateral

tubal obstruction).

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

Group A 12 9 (18)/5 3 (5)/1 NS

Group B 20 16 (16)/9 4 (8)/2 NS

Total 32 25 (34)/14 7 (13)/3 NS

a Fisher’s exact test.

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

Fig. 4. Patients’ acceptability during office operative SSG with the Radiographic Tubal Assessment Set (RTAS): incidence of no discomfort � low pain resulted significantly

lower than moderate � severe pain (p < 0.0001).

L. Cobellis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 163 (2012) 62–66 65

Indeed, this procedure was introduced in the late 1980s as adiagnostic procedure in which the fallopian tube is directlyopacified through a catheter placed in the tubal ostium, thushelping to differentiate spasm from true obstruction and to clarifydiscrepant findings from other tests. SSG is a transvaginaloutpatient procedure, recommended specifically for the diagnosisand treatment of proximal tubal blockage [10]. Therefore operativerecanalization, where a catheter and guide wire system is used toclear PTO is rarely performed and only by trained interventionalradiologists and successfully completed in most patients (71–92%)[5].

Proximal Fallopian tube obstruction is the main indication forthis procedure [11,12,14]. This is due to practical considerationsand also because the anatomical position in the abdomen make thedistal Fallopian tube an organ which is often involved in differentcomorbidities (such as pelvic inflammatory disease, previousectopic pregnancy or endometriosis) [12,16].

Pregnancy rates after the procedure have been variable, with anaverage rate of 30% (22–65%) [5,16]. The same catheterizationtechnique used in fallopian tube recanalization is currently beingexplored for use in tubal sterilization [16].

In the present study we evaluated treatment efficacy andpatient acceptability of the new RTAS for an office operative SSG inorder to recanalize fallopian tube obstruction. In all cases who hada previous hysterosalpingographic diagnosis of tubal obstruction,we performed a standard HSG and an operative disobstruction bydirect insufflation of the contrast medium in the tubal lumen. Inthis way we obtained recanalization in 75.6% of the cases. Thistechnique offers several advantages in terms of proceduralelements and patient security.

In particular, the RTAS improves the possibility of reducing thein utero insufflation pressure, as a consequence of a selectiveaction on the tubal lumen, avoiding either in utero pressuredispersal or spread to the contralateral tube. Additionally, theapplication of the guide-wire, whose effectiveness in achievingtubal recanalization was proven in previous studies [17–20],turned out to be a successful integral part of the present method ofSSG. Furthermore, nowadays, the use of a water-soluble contrastmedium lowers the risk of lymphatic or vascular intravasation,which can be clinically significant and dangerous [17].

Moreover we evaluated patient acceptability of SSG with theRTAS. The overall compliance with the technique was really highwith 69.7% of the women experiencing no pain or low pain. Theadvantage of using this office operative technique is self-evident ifwe consider the patient’s compliance: in most examinations onlyslight pain or a feeling of discomfort during or at the end of theexamination (mean pelvic pain 2.9 � 2.2 in the 0–10 VAS) wasreported, which is comparable to the level of pain felt duringtransvaginal ultrasound. Sometimes the worst discomfort was linkedonly to the introduction or withdrawal of the speculum.

Therefore, the RTAS can be considered a safe and effective toolto perform this office operative procedure for tubal recanalization,with high acceptability for the patient.

Additionally, as we performed a standard HSG before eachoperative procedure, we suggest the use of the RTAS to perform aone-step diagnostic and operative procedure, with the clearadvantage of reducing operative time and patient radiationexposure. Indeed, this technique let us perform an operativerecanalization in an office setting, right after a diagnosis of tubalobstruction is made. Moreover, this method exposes the patient toa single radiation dose, rather than submit her to a second SSG. Arecent paper showed that the radiation dose delivered in a singleprocedure unifying HSG and tube recanalization was significantlydifferent than using two consecutive HSGs, and the latter methodshowed a significantly lower pregnancy rate [21].

Indeed, potential adverse health effects associated with radiationexposure are an important factor to consider when selecting patientsfor repeated radiologic procedures [8,9]. Therefore changes instandard HSG protocols intended to limit the number of exposures,such as elimination of the routine oblique and lateral radiographicprojections, and the use of digital fluoroscopy for HSG have reducedradiation exposure [9,22,23]. Besides, the radiation dose to theovaries from the present procedure is approximately 1 mSv, a dosethat is within accepted limits for women of reproductive age, asrecommended in the recent American College of Radiology whitepaper on radiation dose in medicine [24].

Although the fertilized gamete is radiosensitive, the ovum beforefertilization is relatively radioresistant. Selective salpingographywith fallopian tube recanalization is performed in the follicularphase of the ovulatory cycle to ensure that the patient is not

L. Cobellis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 163 (2012) 62–6666

pregnant and to minimize potential biological damage [10].Moreover, as in our study we achieved a 75.6% rate of tubalrecanalization, only seven patients were sent for laparoscopy, whichrequires anesthesia, and has higher costs, being a surgical technique[5,25].

These preliminary results showed that the RTAS can beconsidered a safe and effective tool to perform this office operativeprocedure for tubal recanalization, with high acceptability for thepatient. Further studies are in progress in order to replicate andextend these findings. Actually a larger number of patients are incourse of enrolment to gain strong conclusions and to define apossible role of SSG not only for the treatment of proximal tubalobstruction, but also for other types of fallopian blockage, such asisthmic portion obstruction.

Indeed, since the results of a recent meta-analysis showed thatpatient characteristics, such as female age, duration of subfertilityand BMI, were not associated with the accuracy of HSG [26], a one-step diagnostic and operative procedure in an office setting shouldbe an optimal solution for all infertile patients as well. Finally, wesuggest that a possibility for the future is the implementation of asimilar office operative approach by using the RTAS undersonographic guidance.

References

[1] Serafini P, Batzofin J. Diagnosis of female infertility. A comprehensive approach.Journal of Reproductive Medicine 1989;34(January (1)):29–40. Review.

[2] Allahbadia GN, Mangeshikar P, Pai Dhungat PB, Desai SK, Gudi AA, Arya A.Hysteroscopic Fallopian tube recanalization using a flexible guide cannula andhydrophilic guide wire. Gynaecological Endoscopy 2000;9:31–5.

[3] Novy MJ, Thurmond AS, Patton P, Uchida BT, Rosch J. Diagnosis of cornualobstruction by transcervical fallopian tube cannulation. Fertility and Sterility1988;50(September (3)):434–40.

[4] Woolcott R. Proximal tubal occlusion: a practical approach. Human Repro-duction 1996;11(September (9)):1831–3.

[5] Al-Jaroudi D, HerbaMJ, Tulandi T. Reproductive performance after selective tubalcatheterization. Journal of Minimally Invasive Gynecology 2005;12(March–April (2)):150–2.

[6] Guidelines for practice. Birmingham, AL: American Fertility Society; 1993.[7] Confino E, Friberg J, Gleicher N. Transcervical balloon tuboplasty. Fertility and

Sterility 1986;46(November (5)):963–6.[8] Kerin JF. New methods for transcervical cannulation of the Fallopian tube.

International Journal of Gynaecology and Obstetrics 1995;51(December(Suppl. 1)):S29–39.

[9] Phillips J, Cochavi S, Silberzweig JE. Hysterosalpingography with use of mobileC-arm fluoroscopy. Fertility and Sterility 2010;93(April (6)):2065–8 (Epub2009 Feb 6).

[10] Thurmond AS, Machan LS, Maubon AJ, Rouanet JP, Hovsepian DM, Moore A,et al. A review of selective salpingography and fallopian tube catheterization.Radiographics 2000;20(November–December (6)):1759–68.

[11] Royal College of Obstetricians and Gynaecologists. Royal College of Obstetri-cians and Gynaecologists evidence-based clinical guidelines. Guideline Sum-mary No. 2: the initial investigation and management of the infertile couple.BJU International 1999;83(6):636–40.

[12] National Institute for Clinical Excellence. Fertility: assessment and treatmentfor people with fertility problems. In: Clinical guideline 11. London: NationalInstitute for Clinical Excellence; 2004.

[13] Downes E, Al-Azzawi F. How well do perimenopausal patients accept outpa-tient hysteroscopy? Visual analogue scoring of acceptability and pain in 100women. European Journal of Obstetrics Gynecology and Reproductive Biology1993;48(January (1)):37–41.

[14] Wilkes S, Rubin G, Crosland A, Hall N, Murdoch A. Patient and professionalviews of open access hysterosalpingography for the initial management ofinfertility in primary care. British Journal of General Practice 2009;59(May(562)):336–42.

[15] Das S, Chin KA. A study of pre-referral evaluation of infertile couples. Journal ofObstetrics and Gynaecology 2003;23(1):70.

[16] Papaioannou S, Bourdrez P, Varma R, Afnan M, Mol BW, Coomarasamy A. Tubalevaluation in the investigation of subfertility: a structured comparison oftests. BJOG 2004;111(December (12)):1313–21.

[17] Papaioannou S, Afnan M, Girling AJ, Coomarasamy A, Ola B, Olufowobi O, et al.The effect on pregnancy rates of tubal perfusion pressure reductions achievedby guide-wire tubal catheterization. Human Reproduction 2002;17(August(8)):2174–9.

[18] Gleicher N, Redding L, Parrilli M, Karanade V, Pratt D. Wire-guide cannulationalone is o treatment of proximal tubal occlusion. Human Reproduction1994;9:1109–11.

[19] Lang EK, Dunaway HH. Recanalization on of obstructed fallopian tube byselective salpingography and transvaginal bougie dilatation: outcome andcost analysis. Fertility and Sterility 1996;66:210–5.

[20] Thurmond AS, Rosch J. Non-surgical Fallopian tube recanalization for treat-ment of infertility. Radiology 1990;174:371–4.

[21] Mallarini G, Saba L. Role and application of hysterosalpingography and Fal-lopian tube recanalization. Minerva Ginecologica 2010;62(December (6)):541–9.

[22] Perisinakis K, Damilakis J, Grammatikakis J, Theocharopoulos N, Gourtsoyian-nis N. Radiogenic risks from hysterosalpingography. European Radiology2003;13:1522–8.

[23] Gregan ACM, Peach D, McHugo JM. Patient dosimetry in hysterosalpingog-raphy: a comparative study. British Journal of Radiology 1998;71:1058–61.

[24] Amis Jr ES, Butler PF, Applegate KE, Birnbaum SB, Brateman LF, Hevezi JM, et al.American College of Radiology white paper on radiation dose in medicine.Journal of the American College of Radiology 2007;4:272–84.

[25] Allahbadia GN, Merchant R. Fallopian tube recanalization: lessons learnt andfuture challenges. Womens Health (London England) 2010;6(July (4)):531–48.quiz 548–9.

[26] Broeze KA, Opmeer BC, Van Geloven N, Coppus SF, Collins JA, Den Hartog JE,et al. Are patient characteristics associated with the accuracy of hysterosal-pingography in diagnosing tubal pathology? An individual patient data meta-analysis. Human Reproduction Update 2011;17(May–June (3)):293–300(Epub 2010 Dec 8).