FERTILITY AND STERILITY威

VOL. 72, NO. 5, NOVEMBER 1999

Copyright ©1999 American Society for Reproductive Medicine
Published by Elsevier Science Inc.
Printed on acid-free paper in U.S.A.

A randomized, prospective, controlled

study of laparoscopic dye studies and
selective salpingography as diagnostic
tests of fallopian tube patency
Robert Woolcott, C.R.E.I., Sonya Fisher, Jane Thomas, and Wendy Kable
Lingard Fertility Centre, Merewether, New South Wales, Australia

Objective: To determine and compare the relative merits of laparoscopic dye (LD) studies and selective
salpingography (SS) as diagnostic tests of fallopian tube patency.
Design: Randomized, prospective, controlled study.
Setting: University-associated assisted reproduction unit.
Patient(s): Two hundred seventy-eight women undergoing investigation of infertility.
Intervention(s): Allocation to the performance of either LD studies followed by SS or SS followed by LD
studies conducted sequentially under general anesthesia.
Main Outcome Measure(s): Detection of fallopian tube occlusion, including the site of obstruction and
evidence of peritubal or pelvic disease.
Result(s): When diagnosis was compared by the first test used, 16 (11.9%) of 135 patients had proximal tubal
occlusion at LD studies versus 5 (3.6%) of 138 at SS. Twelve (5.6%) of 122 patients had distal tubal occlusion
at LD studies versus 14 (10.5%) of 133 at SS. Fifteen (11.1%) of 135 patients had peritubal disease at LD
studies versus 3 (2.52%) of 119 at SS. When diagnosis was compared by individual tubes, the results were
similar. Among patients who had proximal occlusion and otherwise normal tubes by both methods, endome-
triosis was present in 72.2%.
Conclusion(s): Selective salpingography is a better diagnostic test of proximal tubal occlusion than are LD
studies. There is no difference between SS and LD studies as a diagnostic test of distal tubal occlusion.
Laparoscopic dye studies are a better diagnostic test for assessing peritubal disease than is SS. There may be
an association between endometriosis and proximal tubal occlusion. Selective salpingography and LD studies
are complementary investigations of the fallopian tubes. (Fertil Steril威 1999;72:879 – 84. ©1999 by American
Society for Reproductive Medicine.)
Key Words: Fallopian tube patency tests, laparoscopic dye studies, selective salpingography, endometriosis

Received March 5, 1999;

revised and accepted June
2, 1999.
Presented in part at the
13th Annual Meeting of the
European Society of
Human Reproduction,
Edinburgh, United
Kingdom, June 23–25,
1997.
Reprint requests: Robert
Woolcott, M.B., B.S., Suite
12, 50 Glebe Road, The
Junction, New South Wales
2291 Australia (FAX: 61-2-
49695135; E-mail: woolcott
@hunterlink.net.au).
0015-0282/99/$20.00
PII S0015-0282(99)00382-9
A universally agreed-upon, “gold standard”
diagnostic test of fallopian tube patency has not
been established. However, accurate diagnosis
is essential to the ability to assess the results of
any treatment used for the management of ap-
parent fallopian tube occlusion or disease.
Should the method of assessment of tubal pa-
tency lead to a spurious diagnosis of occlusion
or, conversely, inherently treat intraluminal pa-
thology, then the results and interpretation of
any subsequent therapy will be misleading
(1, 2). A variety of investigations might fill this
role; laparoscopic dye (LD) studies, hystero-
salpingography, selective salpingography (SS),
and falloposcopy all could be considered.
The aim of this study was to provide infor-
mation that would better define the roles of two
tests of tubal patency, LD studies and SS,
which were chosen for comparison on the basis
of their potential to fulfill the role of gold
standard, their use in tertiary referral institu-
tions, and their apparent individual advantages
in particular clinical settings such as peri-
adnexal disease or proximal tubal occlusion
(PTO).
MATERIALS AND METHODS
A randomized, prospective, controlled study
of SS and LD studies was performed to assess

879
the relative merits of each as a diagnostic test of tubal
patency and to analyze its potential advantages and limita-
tions. Approval from the hospital’s institutional review
board (quality assurance committee) was obtained before the
study was begun.
Two hundred seventy-eight patients who presented for
investigation of infertility between October 1995 and Sep-
tember 1998 were enrolled in the study. Patients with a
history of salpingectomy or ectopic pregnancy were ex-
cluded from enrollment.
Patients were randomized by off-site, computer-generated
random number to one of two groups: in group A, LD studies
were performed first, followed by SS, and in group B, SS
was performed first, followed by LD studies. Both tests were
performed sequentially under the same general anesthetic.
The main outcome measures were evidence of fallopian
tube patency, the site of obstruction, if any, and evidence of
peritubal disease. The results were assessed statistically by
determining exact probability using the two-tailed Fisher’s
exact test.
Laparoscopic dye studies were performed by double
puncture (peri-umbilical and suprapubic) with a 7-mm non-
disposable laparoscope. A Spackmann cervical insufflation
cannula was placed in the cervical canal and dilute methyl-
ene blue dye was injected into the uterine cavity. The flow of
dye, distention of the fallopian tubes, evidence of peritoneal
spill to confirm patency, and presence of peritubal or pelvic
disease (or the absence of these phenomena) were observed
simultaneously through the laparoscope.
Proximal tubal occlusion was diagnosed when there was
no externally visible passage of dye beyond the isthmus of
the fallopian tube (no distention of, movement into, or clear
change in color of the tube). Distal tubal occlusion (DTO)
was diagnosed when dye was seen to pass into at least the
ampullary segment of the tube but not beyond the fimbria
into the peritoneal cavity, or when there were externally
obvious hydrosalpinges. Peritubal disease was defined by the
presence of adhesions that were attached to or were in direct
proximity to any part of the fallopian tube.
Selective salpingography was performed with the Fallo-
potorque cannula set (Cook IVF, Queensland, Australia),
with Ultravist-370 contrast medium (Iopromide 76.9%;
Schering AG, Germany) and fluoroscopic assessment. The
salpingography catheter was directed to and abutted against
the inner fallopian tube orifice (without entry into the tube)
under fluoroscopic visualization. Contrast medium then was
injected and its passage (if any) into the fallopian tube, the
flow of contrast along the tube, evidence of PTO or DTO,
peritoneal spill, and evidence of peritubal loculation were
assessed by two observers.
Proximal tubal occlusion was diagnosed by the absence of
contrast medium entering the tube or passing beyond the
isthmus of the tube (defined by the uterotubal junction and
880 Woolcott et al. Diagnostic studies of tubal patency
the point of increase in tubal diameter at the isthmo-ampul-
lary junction. Distal tubal occlusion was diagnosed on the
basis of evidence of contrast medium within the ampulla of
the tube but not entering the peritoneal cavity. Peritubal
disease was diagnosed on the basis of loculation of contrast
medium around the fallopian tube and/or restriction of flow
of contrast medium away from the distal tube (3).
Where appropriate, any diagnosed tubal occlusion or dis-
ease was treated after the conclusion of both randomized
tests. If possible, the treatment of PTO was performed during
the same operation by radiologically guided tubal catheter-
ization and/or wire guide recanalization, when necessary,
using methods previously described (3). Likewise, the treat-
ment of DTO and peritubal disease also was performed
sequentially by laparoscopic methods after the completion of
these investigations, when suitable.
RESULTS
Of the 278 patients enrolled in the study, 5 patients were
excluded from analysis, 2 because intra-abdominal adhe-
sions prevented visualization of the fallopian tubes at lapa-
roscopy and 3 because of the presence of a grossly distorted
intrauterine anatomy as a result of leiomyomas (2 patients)
or intrauterine adhesions (1 patient) preventing access to the
internal fallopian tube orifice with SS catheters. Two of these
5 patients were from group A and 3 were from group B.
Thus, the results of investigations on 273 patients were
analyzed. One hundred thirty-seven patients were random-
ized to group A; 2 were excluded from analysis and 135
patients with 270 potential fallopian tubes were analyzed.
One hundred forty-one patients were randomized to group B;
3 were excluded from analysis, and 138 patients with 276
potential fallopian tubes were analyzed. There were no dif-
ferences in mean age (31.7 years in group A versus 32.1
years in group B), parity (0.9 in group A versus 0.7 in group
B), duration of infertility (15.5 months in group A versus
16.3 months in group B), or history of salpingitis (2.3% in
group A versus 2.9% in group B) between the two groups.
When diagnosis was compared by the first test performed,
PTO was observed in 16 (11.9%) of 135 patients who
underwent LD studies first and in 5 (3.62%) of 138 patients
who underwent SS first (P⫽.0184). Distal tubal occlusion
was observed in 12 (9.84%) of 122 patients who underwent
LD studies first and in 14 (10.5%) of 133 patients who
underwent SS first (P⬎.05, not significant [NS]). Evidence
of peritubal disease was present in 15 (11.1%) of 135 pa-
tients at LD studies versus 3 (2.52%) of 119 patients at SS
(P⫽.0126) (Table 1). Similarly, when individual fallopian
tubes were compared, 27 (10%) of 270 had evidence of PTO
at LD studies versus 8 (2.9%) of 276 at SS (P⫽.00105),
and 21 (8.61%) of 244 had evidence of DTO at LD studies
versus 24 (9.02%) of 266 at SS (P⬎.05, NS) (Table 2).
When diagnosis was compared by the sequence of the
Vol. 72, No. 5, November 1999

TABLE 1
Group A initial test (laparoscopic dye studies) versus group
B initial test (selective salpingography), by patient.
No. with No. with
PTO/total DTO/total
no. who no. who
underwent underwent
procedure procedure
Procedure (%) (%)
Laparoscopic dye studies 16/135 (11.9) 2/122 (9.84) 15/135 (11.1)
Selective salpingography 5/138 (3.62) 14/133 (10.5) 3/119 (2.52)
P value (Fisher’s exact test) .0184 NS .0126
Note: DTO ⫽ distal tubal occlusion; NS ⫽ not significant; PTO ⫽ proximal
tubal occlusion.
Woolcott. Fallopian tube patency. Fertil Steril 1999.
tests used and by patient, in group A, PTO was diagnosed in
16 (11.9%) of 135 patients (11 bilateral, 5 unilateral) at
initial LD studies versus 6 (4.44%) of 135 patients (3 bilat-
eral, 3 unilateral) at subsequent SS (P⫽.0432). A false-
positive diagnosis of PTO was made in 10 (7.41%) of 135
patients who underwent LD studies. Of the 16 patients with
PTO, 10 had normal distal tubes and 3 had peritubal or distal
tubal disease that fell short of definitive obstruction; these 13
patients were excluded from the analysis for DTO. Three
patients had clear DTO, with externally obvious hydrosal-
pinges. Thus, 122 patients were analyzed for DTO by LD
studies. Twelve (9.84%) of 122 patients had evidence of
DTO at LD studies (9 bilateral, 3 unilateral) versus 16
(12.4%) of 129 at subsequent SS (10 bilateral, 6 unilateral)
(P⬎.05, NS). The denominator was reduced by the exclu-
sion of 6 patients with PTO diagnosed at SS (Table 3).
Peritubal disease secondary to either peritubal adhesions
(6 patients) or endometriosis (9 patients) was present in
group A in 15 (11.1%) of 135 patients at LD studies and in
3 (2.65%) of 113 patients with patent tubes at SS (P⫽.016)
(Table 3). The denominator of the SS group was reduced by
the exclusion of 6 patients with PTO and 16 patients with
DTO diagnosed by SS (Table 3).
Similarly, when diagnosis was compared by the sequence
of the tests used and by individual fallopian tube in group A,
PTO was diagnosed in 27 (10%) of 270 tubes at LD studies
and in 9 (3.3%) of 270 tubes at SS (P⫽.00287). A false-
positive diagnosis of PTO was made in 18 (6.67%) of 270
fallopian tubes in patients who underwent LD studies. Distal
tubal occlusion was diagnosed in 21 (8.61%) of 244 fallo-
pian tubes at LD studies versus 26 (10.08%) of 258 tubes at
SS (P⬎.05, NS).
When diagnosis was compared by the sequence of the
tests used and by patient, in group B, 5 (3.62%) of 138
patients (3 bilateral, 2 unilateral) had apparent PTO at SS
versus 8 (5.8%) of 138 patients (5 bilateral, 3 unilateral) at
FERTILITY & STERILITY威
subsequent LD studies (P⬎.05, NS). A false-positive diag-
nosis of PTO was made in 3 (2.17%) of 138 patients who
underwent LD. Distal tubal occlusion was present in 14
(10.5%) of 133 patients (10 bilateral, 4 unilateral) at SS
versus 10 (7.58%) of 132 patients (7 bilateral, 3 unilateral) at
subsequent LD studies (P⬎.05, NS). The denominator was
No. with reduced by 8 patients with PTO and a further 2 with clear
peritubal
disease/total
laparoscopic evidence of distal occlusion (Table 4).
no. procedure Evidence of peritubal disease was present in group B in 3
(%) (2.52%) of 119 patients without PTO or DTO at SS and in 16
(11.6%) of 138 patients (endometriosis in 11, pelvic adhe-
sions in 5) at LD studies (P⫽.00865) (Table 4).
Similarly, when diagnosis was compared by the sequence
of the tests used and by individual fallopian tube in group B,
PTO was diagnosed in 8 (2.9%) of 276 fallopian tubes at
initial SS versus 13 (4.71%) of 276 fallopian tubes at sub-
sequent LD studies (P⬎.05, NS). A false-positive diagnosis
of PTO was made in 5 (1.81%) of 276 fallopian tubes in
patients who underwent LD studies. Distal tubal occlusion
was diagnosed in 24 (9.02%) of 266 fallopian tubes at SS
(patients with PTO at SS were necessarily excluded from the
analysis for DTO) versus 17 (6.44%) of 264 fallopian tubes
at LD studies (P⬎.05, NS).
Endometriosis was present in 13 (72.2%) of 18 patients
when apparent PTO was diagnosed by either LD studies or
SS and the fallopian tubes appeared otherwise normal. In all
these patients, the disease was mild, limited to peritoneal or
superficial ovarian deposits without direct involvement of
the fallopian tubes.
DISCUSSION
Commonly used investigations of fallopian tube patency
such as LD studies and hysterosalpingography that rely on
the development of sufficient intrauterine pressure to over-
come the physiologic opening pressure of the internal tubal
TABLE 2
Group A initial test (laparoscopic dye studies) versus group
B initial test (selective salpingography), by tube.
No. with No. with
PTO/total DTO/total
no. who no. who
underwent underwent
procedure procedure
Procedure (%) (%)
Laparoscopic dye studies 27/270 (10.0) 21/244 (8.61)
Selective salpingography 8/276 (2.9) 24/266 (9.02)
P value (Fisher’s exact test) .00105 NS
Note: DTO ⫽ distal tubal occlusion; NS ⫽ not significant; PTO ⫽ proximal
tubal occlusion.
Woolcott. Fallopian tube patency. Fertil Steril 1999.
881
 TABLE 3

Laparoscopic dye studies followed by selective salpingography, by patient (group A).

No. with peritubal

No. with PTO/total No. with DTO/total disease/total no.
no. who underwent no. who underwent who underwent
Procedure procedure (%) procedure (%) procedure (%)

Laparoscopic dye studies performed first 16/135 (11.9) 12/122 (9.84) 15/135 (11.1)
Selective salpingography performed second 6/135 (4.44) 16/129 (12.4) 3/113 (2.65)
P value (Fisher’s exact test) .0432 NS .0169
Note: DTO ⫽ distal tubal occlusion; NS ⫽ not significant; PTO ⫽ proximal tubal occlusion.
Woolcott. Fallopian tube patency. Fertil Steril 1999.

orifice can produce false-positive diagnoses of apparent
tubal occlusion (2, 4 – 6). It may not be possible to attain
sufficient intrauterine pressure to produce tubal flow because
of the leakage of dye or contrast medium around the inser-
tion site of the instilling device within the cervix. Further,
uterine distention during the instillation of fluid may cause
myometrial compression of the transmural portion of the
fallopian tube.
Conversely, it is important to acknowledge the potential
therapeutic effect of the passage of any implement into the
fallopian tube, whether it be a salpingography catheter, a
falloposcope, or a wire guide (2, 7–9). All these devices have
the ability to treat intraluminal obstruction when the imple-
ment is passed into the fallopian tube before the test is
performed by inadvertently dislodging debris, mucus plugs,
fine adhesions, endometrial fragments, or polyps. Indeed, the
randomization of sequential tests in this study was specifi-
cally intended to overcome this potential confounding factor.
The method used to assess tubal patency should not involve
the entry of any instrument into the tube because this will
increase the risk of false-negative results and affect the
evaluation of therapies for tubal occlusion. Accurate infor-
mation concerning the properties and limitations of tests of
fallopian tube patency is essential to the treatment of patients
with infertility.
The results of this study clearly illustrate the differing
abilities of LD studies and SS to assess proximal or distal
fallopian tube patency and peritubal disease. The study de-
sign provides a substantial degree of certainty that the results
obtained represent an accurate appraisal of the relative ca-
pabilities of each test in that patients were randomized for
their initial test (LD studies or SS) and all patients also
served as their own sequential control (LD studies followed
by SS, or vice versa) to provide a secondary method of
assessing the investigations.
Selective salpingography was a superior test for the as-
sessment of PTO when the first tests performed were com-
pared (LD studies versus SS) and also in group A. In group
B, however, there was no difference between the two tests.
These results demonstrate the tendency of LD studies to
produce a false-positive diagnosis of PTO; this occurred in
10 (7.4%) of 135 patients and 18 (6.7%) of 270 fallopian
tubes in group A and in 3 (2.2%) of 138 patients and 5
(1.8%) of 276 fallopian tubes in group B. We believe the
difference between the groups represents the previously doc-
umented therapeutic effect of SS (2). Laparoscopic dye
studies, however, have the inherent advantage of enabling
the direct visualization of the external peritoneal surfaces of
the fallopian tube. It is not surprising that the study demon-
strated a greater ability of this test to identify peritubal
disease. Despite this, the study failed to demonstrate a dif-
ference in the ability of either test to identify DTO.

TABLE 4

Selective salpingography followed by laparoscopic dye studies, by patient (group B).

No. with peritubal

No. with PTO/total No. with DTO/total disease/total no.
no. who underwent no. who underwent who underwent
Procedure procedure (%) procedure (%) procedure (%)

Selective salpingography performed first 5/138 (3.62) 14/133 (10.5) 3/119 (2.52)
Laparoscopic dye studies performed second 8/138 (5.8) 10/132 (7.58) 16/138 (11.6)
P value (Fisher’s exact test) NS NS .00865
Note: DTO ⫽ distal tubal occlusion; NS ⫽ not significant; PTO ⫽ proximal tubal occlusion.
Woolcott. Fallopian tube patency. Fertil Steril 1999.

882 Woolcott et al. Diagnostic studies of tubal patency Vol. 72, No. 5, November 1999
 The information provided by this study supports the clin-
ical practice of assessing the proximal and distal segments of
the fallopian tube by different methods. The results strongly
indicate that it is wise to use a variety of methods to assess
the fallopian tubes, particularly when apparent PTO is
present. Laparoscopic dye studies and SS are suited to de-
termining patency. Although neither falloposcopy nor sal-
pingoscopy was evaluated in this study, it is reasonable to
suggest that they also might be used differentially to assess
the condition of the proximal and distal endosalpinx, al-
though further examination of this hypothesis is necessary.
We believe that the high incidence of endometriosis in
patients with proximal occlusion and otherwise normal fal-
lopian tubes diagnosed by either method is significant. Sim-
ilar observations have been made by Karande et al. (10) and
by us during the routine management of PTO (2). The exact
mechanism of this association is unclear. We hypothesize
that a combination of the deposition intraluminal debris from
retrograde menstruation and elevated tubal perfusion pres-
sures (6) resulting from an increase in myosalpingeal tone
caused by an elevated level of prostaglandins (11) in the
peritoneal fluid in patients with endometriosis leads to a
functional intraluminal obstruction of the isthmus of the
fallopian tube. The disturbance in the uterotubal fluid flow
that has been identified in patients with endometriosis (12)
also may contribute to localized isthmic deposition of men-
strual debris.
The relative ease with which apparent PTO in patients
with otherwise normal-appearing tubes can be treated with
transcervical tubal catheterization techniques also supports
this hypothesis. The high pregnancy rates that are seen after
such treatment, which can be performed concurrently with
the laparoscopic ablation of peritoneal deposits of endome-
triosis, are consistent with an absence of structural pathology
of the endosalpinx or myosalpinx. Moreover, when resection
and reanastomosis is performed for apparent PTO, most
patients have no identifiable intraluminal or histologic pa-
thology (13), and we speculate that the fragile intraluminal
debris is dislodged during manipulation and resection of the
tubal segment or during processing of the histologic specimen.
One of the difficulties associated with the use of LD
studies and SS as dual tests of fallopian tube patency is the
fact that they commonly are performed by different medical
specialists. This may generate conflicting opinions between
gynecologists and radiologists concerning the indications
for, degree of procedural difficulty of, interpretation of, and
potential for complications of each test because of their
differing perspectives. However, these tests can be per-
formed simply and safely by those with appropriate training
in both laparoscopy (14, 15) and transcervical tubal cathe-
terization (2, 5, 16).
Laparoscopy has been used in routine gynecologic prac-
tice for many years; however, until recently, SS was per-
formed only at tertiary referral institutions. This was largely
FERTILITY & STERILITY威
because of the perceived technical difficulty of the transcer-
vical approach to the fallopian tube associated with the
inability to guide the cannula to the internal tubal ostia. Most
tubal cannulation systems lacked the rotational torque nec-
essary to place the cannula accurately. Newer implements,
such as those used in this study, make it simple for almost
every clinician with an average knowledge of uterine anat-
omy and technical skill to perform this procedure. Even the
most basic fluoroscopic equipment will suffice to assess the
passage of contrast medium beyond the tubal isthmus and
provide evidence of tubal patency. Thus, most operating
theaters will be able to assist the gynecologist in performing
the combination of SS and LD studies with the cooperation
of their radiologic colleagues where appropriate.
We conclude that SS is a better diagnostic test of PTO
than LD studies, and that there is no difference between SS
and LD studies as diagnostic tests of DTO. Selective salpin-
gography is a better candidate for a gold standard test of
tubal patency because it is less likely to produce a false-
positive diagnosis, in the absence of the possibility of a
false-negative diagnosis, except when therapeutic entry of
implements into the fallopian tube is used. However, LD
studies are a better diagnostic test than SS for assessing
peritubal disease. Further, there may be an association be-
tween endometriosis and PTO. Finally, SS and LD studies
are complementary investigations of the fallopian tubes.
Both need to be considered to obtain a comprehensive and
accurate assessment of tubal status.
Acknowledgments: The authors thank the staff of the Lingard Private
Hospital, and especially Mrs. Ileen Hull for her gracious help and encour-
agement. We also thank Mr. Geoff Reeves of Cook Australia for providing
support and assistance for this study. Finally, we thank Dr. Masood Afnan
of the Assisted Conception Unit, University of Birmingham, Birmingham
Women’s Hospital, West Midlands, United Kingdom, and two unnamed
referees, who together provided significant editorial advice and assistance
with this manuscript.
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Vol. 72, No. 5, November 1999