Middle East Fertility Society Journal (2015) 20, 108–113

Middle East Fertility Society

Middle East Fertility Society Journal

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ORIGINAL ARTICLE

The safety and acceptability of saline

infusion sonography versus hysterosalpingography
for evaluation of tubal patency in infertile women
a,* b
Mohamed Rezk , Mohamed Shawky

a
Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, Egypt b
Department of Radiology, Faculty of Medicine, Menoufia University, Egypt

Received 6 May 2014; accepted 10 June 2014

Available online 4 August 2014

KEYWORDS
Saline infusion sonography;
Hysterosalpingography;
Tubal patency; Infertility
Abstract Objective: To assess the efficacy, safety and acceptability of saline infusion sonography (SIS) in
comparison to hysterosalpingography (HSG) in the evaluation of tubal patency in infertile women.
Materials and methods: In this prospective study, 104 consecutive infertile women underwent SIS and
HSG for tubal patency followed by laparoscopy with dye test as the gold standard test. Test parameters,
safety and acceptability of both methods were assessed.
Results: SIS showed patency in 90 (86.5%) tubes, HSG in 85 (81.7%) tubes, and laparoscopy in 75
(72.1%) tubes. SIS and laparoscopy agreed in 15 out of 29 occluded tubes (concordance, 51.7%) while
HSG and laparoscopy agreed in 11 out of 29 occluded tubes (concordance, 37.9%). The sen-sitivity,
specificity, PPV, NPV were 52%, 95%, 79%, 84% for SIS and 38%, 96%, 79%, 80% for HSG
respectively. There were a significant number of women who experienced pain, syncopy and
cervicovaginal lacerations during HSG examination in comparison to SIS (P < 0.001). SIS was more
acceptable than HSG as a screening test for tubal patency regarding the overall discomfort and the
overall satisfaction rate.
Conclusion: Although HSG is the standard screening test for the diagnosis of tubal infertility, the
present study confirmed the higher sensitivity, safety and acceptability of SIS compared to HSG for the
evaluation of tubal patency in infertile women.
2014 Production and hosting by Elsevier B.V. on behalf of Middle East Fertility Society.

*
Corresponding author. Tel.: +20 1006237186.
E-mail address: m_rezk9207@yahoo.com (M. Rezk).
Peer review under responsibility of Middle East Fertility Society.
Production and hosting by Elsevier
1. Introduction
Infertility is defined as the failure to conceive after one year of
regular unprotected intercourse (1). Infertility etiology is
multifactorial, the role of a tubal factor in infertility is increas-ing,
and currently, it determines 30% to 35% of all infertility cases (2).

http://dx.doi.org/10.1016/j.mefs.2014.06.003
1110-5690 2014 Production and hosting by Elsevier B.V. on behalf of Middle East Fertility Society.
Safety and acceptability of saline infusion sonography versus hysterosalpingography 109

Screening for tubal occlusion is part of the investigation of

subfertile couples and is classically performed using hysterosal-
pingography (HSG) or laparoscopy with chromotubation (3).
The technique of saline infusion sonohysterography (SIS)
which entails the instillation of a fluid into the uterine cavity
under ultrasound scan was initially used for assessment of the
uterine cavity (4,5).
Recently, SIS was used as the initial step for the assessment of
fallopian tube patency because it is a simple, safe, and well-
tolerated technique with a low risk of adverse effects and severe
complications (6,7).
Initially infertile patients should perform HSG, followed by
SIS in all patients with suspected bilateral proximal tubal
obstruction based on HSG. If SIS confirms the previously shown
obstruction, only then should the patient undergo the more
expensive and more invasive diagnostic laparoscopy (6).
The aim of our study was to assess the efficacy, safety and
acceptability of saline infusion sonography (SIS) in compari-son
to hysterosalpingography (HSG) for the evaluation of tubal
patency in infertile women with laparoscopy being the gold
standard test.

2. Patients and methods

We conducted a prospective observational study of 104 infer-tile Figure 1 HSG reveals bilateral patent tubes (arrows).
couples from February 2013 to February 2014. Patients were
recruited from the Obstetric and Gynecological outpa-tient Clinic,
Menoufia University Hospital, Egypt.
The institutional review board approved the study protocol
and an informed consent was obtained from all participants prior
to commencing the study.
After revising the test validity parameters of HSG in com-
parison to SIS from the literature. Accordingly, at alpha = 0.05
and a study power of 80% a total sample size of 90 participants
was required after adding a percentage of 10% for possible drop
out cases during the study.
All patients initially underwent routine evaluation that
included a complete history and physical examination, semen
analysis and hormonal assessment. The study group was selected
with regard to appropriate inclusion and exclusion cri-teria. The
inclusion criteria were: unexplained infertility, age between 20
and 40 years, infertility by at least 1 year. The exclu-sion criteria
were serious semen abnormalities, FSH > 15 mIU/ mL and
contraindications for HSG or laparoscopy.
Saline infusion sonography (SIS) and hysterosalpingogra-phy
(HSG) were performed in all cases. Laparoscopy was performed
within one week from the screening tests.
Figure 2 HSG reveals unilateral patent tube (arrow).
2.1. Screening tests
was introduced into the lower uterine cavity. A 20-ml syringe
loaded with 0.9% saline solution was attached to the external end
Early in the post-menstrual period (days 4–7), HSG was per- of the catheter after removal of the speculum and the tenaculum,
formed in the radiology department. The Fallopian tubes were and ultrasound probe was reintroduced into the vagina. Injecting
considered patent when at least one tube was observed in the 20–40 ml of the solution was introduced into the catheter. The
HSG (Figs. 1 and 2) and occluded if bilateral (Fig. 3).
patency of Fallopian tubes was determined by the presence of
The SIS procedure was performed in the Obstetrics and fluid in the Douglas pouch which indicates the patency of at least
Gynecology department by a different physician blinded to the one tube (Fig. 4). Absence of fluid in the Douglas pouch indicated
result of HSG after 48 h. After an initial evaluation of the uterus tubal occlusion (Fig. 5).
and adnexa by vaginal ultrasound, a Cusco specu-lum was
Prophylactic antibiotics in the form of Doxycycline 100 mg 1
inserted and the cervix washed with an antiseptic solu-tion. The
h before and 200 mg orally after the procedure and analgesics in
anterior lip of the cervix was grasped with a single-toothed
the form of Diclofenac 50 mg orally half an hour prior to
tenaculum and a pediatric Foley catheter (8–10 f)
examination were given to all the patients.
110
Figure 3 HSG reveals bilateral tubal occlusion (arrows).
Figure 4 SIS reveals fluid in the Douglas pouch indicating patent
tubes (arrow).
2.2. Reference standard
Laparoscopy and dye test was carried out at the Department of
Obstetrics and Gynecology of Menoufia University Hospital
under general anesthesia by staff gynecologists. A Storz laparo-
scope was used, artificial pneumoperitoneum was reached while
using CO2. A thorough inspection of the pelvis, internal genita-lia,
appendix, and liver region was performed, followed by test-ing
the patency of the Fallopian tubes using dye. A dilute (0.5%)
solution of methylene blue dye (15–20 mL) was injected through
the uterine cervix with metal cannula. Tubal status (patency or
occlusion) and periadnexal adhesions were assessed and managed
by a surgeon as needed. The data of laparoscopy were registered
to a standardized form.
The primary outcome of the study was test parameters of
Saline infusion sonography (SIS) and Hysterosalpingography
M. Rezk, M. Shawky
Figure 5 SIS reveals absence of fluid in the Douglas pouch indicating
tubal occlusion (arrow).
104 Patients enrolled
Screening Tests
HSG SIS
Laparoscopy
HSG= Hysterosalpingography
SIS=Saline infusion sonography
Figure 6 The flow diagram.
(HSG) in terms of sensitivity, specificity, positive predictive value
(PPV), negative predictive value (NPV) and accuracy.
Secondary outcomes included safety and acceptability. Safety
was assessed by comparing the prevalence of immediate
complications (pain requiring additional analgesia, fever, shiv-
ering, syncopy and cervical lacerations). Acceptability included
assessment of overall discomfort, likelihood of recommending the
method to other women and overall satisfaction rate (Fig. 6).
2.3. Statistical analysis
Data were collected, tabulated, statistically analyzed by com-
puter using SPSS version 16 (SPSS Inc, Chicago, IL, USA).
2.3.1. Descriptive statistics
Quantitative data are expressed to measure the central ten-dency
of data and diversion around the mean, mean (x) and standard
deviation (SD) and range.
Qualitative data are expressed in number and
percentage.
Safety and acceptability of saline infusion sonography versus hysterosalpingography 111

Table 1 Patient characteristics (n = 104). Table 5 Adverse effects of the screening tests.
Mean ± SD Range HSG SIS Chi square P value
Age (years) 27.47 ± 5.86 20–40 Pain requiring analgesia 72 47 12.78 <0.001
Parity 1.25 ± 1.18 0–3 Fever 12 11 0.209 >0.05
Duration (years) 3.56 ± 2.33 1–10 Shivering 11 10 0.570 >0.05
No % Syncope 19 9 18.75 <0.001
Cervical lacerations 30 5 21.64 <0.001
Type
Primary 41 39.4
Secondary 63 60.6
Past pelvic surgery P value >0.05 was considered statistically non significant. P
Yes 59 56.7 value 60.05 was considered statistically significant.
No 45 43.3 P value 60.001 was considered statistically highly significant.
Past history of endometriosis
P-value in bold is statistically significant.
Yes 0 0
No 104 100
3. Results

Table 2 Tubal patency by screening tests and laparoscopy. Table 1 displays the patient characteristics.
Table 2 reveals tubal patency by screening tests (SIS &
No % HSG) and laparoscopy, SIS showed patency in 90 (86.5%)
SIS tubes, HSG in 85 (81.7%) tubes, and laparoscopy in 75
Occluded 19 18.3 (72.1%) tubes.
Patent 85 81.7 Table 3 reveals concordance between the screening tests
HSG and laparoscopy, SIS and laparoscopy agreed in 15 out of 29
Occluded 14 13.5 occluded tubes (concordance, 51.7%) while HSG and laparos-
Patent 90 86.5 copy agreed in 11 out of 29 occluded tubes (concordance,
Laparoscopy 37.9%).
Occluded 29 27.9 Table 4 displays the test performance parameters of the
Patent 75 72.1 screening tests. The sensitivity, specificity, PPV, NPV were
52%, 95%, 79%, 84% for SIS and 38%, 96%, 79%, 80%
for HSG respectively.
Table 5 reveals the adverse effects of the screening tests.
Table 3 Concordance between the screening tests and There were a significant number of women who experienced
pain, syncopy and cervicovaginal lacerations during HSG
laparoscopy. examination in comparison to SIS (P < 0.001).
Laparoscopy Table 6 displays the patient acceptability of the screening
Occluded Patent tests, SIS was more acceptable than HSG as a screening test
SIS for tubal patency regarding the overall discomfort and the

Occluded 15 4
overall satisfaction rate.
Patent 10 75
HSG 4. Discussion
Occluded 11 3
Patent 15 75 HSG is still widely used as a first-line procedure for evaluation
of female infertility. When HSG was originally performed,
with rigid metal cannulae and oil-based or ionic contrast
2.3.2. Analytic statistics media, moderate to severe pain was a common complaint.
Chi-square (x2) test was used to compare categorical HSG, therefore, earned the reputation of being a painful test,
outcomes. which in turn increased the fear of pain from this type of
All these tests were used as tests of significance at procedure (8,9).

Table 4 Test performance parameters of the screening tests.

Screening test Sensitivity Specificity PPV NPV Accuracy Chi square P value
(95% CI) (95% CI) (95% CI) (95% CI) (95% CI)
SIS 52% 95% 79% 84% 83% 0.91 >0.05
HSG 38% 96% 79% 80% 80%
 112
Table 6 Patient acceptability of the screening tests.
HSG
Overall discomfort
1. Moderate/high/extreme 35
2. None or slight 69
Overall satisfaction
1. Very or somewhat satisfied 78
2. Neutral or somewhat not satisfied 26
Would recommend this method to other women
1. Highly or somewhat agree 70
2. Neutral or somewhat disagree 34
With advances in ultrasound imaging, SIS and hysterosal-
pingo-contrast sonography (HyCoSy) have replaced HSG for
evaluation of the uterine cavity and Fallopian tubal patency in
many centers worldwide (8,10–12).
Our study evaluated the performance of SIS in diagnosis of
tubal patency compared to HSG with laparoscopy being the gold
standard test. The test performance parameters of SIS were
superior to HSG in terms of sensitivity and negative pre-dictive
value.
These results are comparable to the numbers calculated in
meta-analysis of Swart and coworkers (13). The authors of meta
analysis limited their assessment to included retrospective cohort
studies, because no RCTs and no prospective cohort studies had
been published investigating the validity of HSG in diagnosing
tubal pathology. The point estimate of 65% (95% CI, 50–78) for
sensitivity and of 83% (95% CI, 77–88) for specificity was
calculated for tubal patency. These calcula-tions were made for
three studies that judged HSG and lapa-roscopy independently
(14–16).
In our study, SIS and laparoscopy agreed in 15 out of 29
occluded tubes (concordance, 51.7%). These results are infe-rior
to previous studies, which have yielded concordance val-ues
between 83 and 86% (17,18). In these previous studies, the
authors used microbubble-microparticle suspension in an aqueous
monosaccharide carrier solution (Echovist) as a med-ium for
amplifying the echo signal which is an expensive med-ium not
available in our country while in our study, we used saline as a
distention medium with pediatric Foley catheter because it is
available and cheap.
In order to provide sterile conditions and to reduce infec-tive
morbidity, prophylactic antibiotics were prescribed to all patients
in our study according to guidelines of the American College of
Obstetricians and Gynecologists (19).
A 2007 Cochrane review on pain relief for HSG summa-rized
eight RCTs involving 570 women. Overall, the conclu-sion was
that there was no evidence of significant benefit in using any
analgesia compared to placebo for pain relief during HSG. Four
RCTs (n = 270) demonstrated evidence of benefit for pain relief
more than 30 min after HSG (20). A 2011 sys-tematic review and
meta-analysis found no beneficial effect of any pharmacological
interventions for pain relief during HSG (21). In our study, all
patients received analgesics in the form of Diclofenac 50 mg
orally half an hour prior to the screening test but the need for
another dose of analgesics was more during HSG than SIS. Also,
the overall discomfort after HSG was greater than SIS.
M. Rezk, M. Shawky
SIS Chi square P value
13 4.76 <0.05
91
96 4.501 <0.05
8
86 3.16 >0.05
18
In our study, more patients suffered from syncope and cer-
vical lacerations during HSG examination secondary to the use of
rigid metal cannulae for the procedure.
In conclusion, our results support the effectiveness of SIS for
the assessment of tubal patency in comparison to HSG because it
is a simple, safe, cheaper, more acceptable technique and without
the risks of irradiations.
Disclosure
We certify that no actual or potential conflicts of interest in
relation to this article exist.
Acknowledgements
The authors would like to acknowledge the contribution of the
residents and nursing staff of the gynecology ward and mem-bers
of the radiology department of Menoufia University Hospital.
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