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hysteroscopic sterilization
techniques: a systematic review
and meta-analysis
lmann, M.D., Ph.D.,c
Claire F. la Chapelle, M.D.,a Sebastiaan Veersema, M.D., Ph.D.,b Hans A. M. Bro
and Frank Willem Jansen, M.D., Ph.D.a
a
Department of Gynaecology and Obstetrics, Leiden University Medical Center, Leiden; b Department of Gynaecology and
Obstetrics, St. Antonius Hospital, Nieuwegein; and c Department of Gynaecology and Obstetrics, VU Medical Center,
Amsterdam, the Netherlands
Objective: To assess whether hysteroscopic sterilization is feasible and effective in preventing pregnancy. Secondarily, to identify risk
factors for failure of hysteroscopic sterilization.
Design: A systematic review and meta-analysis.
Setting: Not applicable.
Patient(s): Women undergoing hysteroscopic sterilization.
Intervention(s): Hysteroscopic sterilization with a commercially available system (Ovabloc Intra Tubal Device, Essure system, or Adiana permanent contraception system).
Main Outcome Measure(s): Successful placement at rst attempt, conrmed correct placement, complications, incidence of pregnancy, and risk factors for placement failure in hysteroscopic sterilization.
Result(s): Of the 429 citations identied, 45 articles were eligible for analyses. No randomized controlled trials (RCTs) were identied,
just cohort studies. Six articles concerned Ovabloc, 37 Essure, and two Adiana sterilization. The probabilities for successful bilateral
placement in a rst attempt for Ovabloc, Essure, and Adiana, were, respectively, in the ranges 78%84%, 81%98%, and 94%. The probabilities of successful bilateral placement could not be pooled because of substantial heterogeneity. The 36 months' cumulative pregnancy rate of Adiana was 16 of 1,000. Reliable pregnancy rates after sterilization with Ovabloc or Essure method could not be
calculated. For all three hysteroscopic techniques, the incidence of complications and their severity has not been studied adequately
and remains unclear. We also found too little evidence to identify risk factors for placement failure.
Conclusion(s): Sterilization by hysteroscopy seems feasible, but the effectiveness and risk factors for failure of sterilization remain
unclear owing to the poor-quality evidence. Both currently applied hysteroscopic sterilization techniques and the coming new
techniques must be evaluated properly for feasibility and effectiveness. Appropriate RCTs and observational studies with sufcient
power and complete and long-term (>10 years) follow-up data on unintended pregnancies
and complications are needed. (Fertil Steril 2015;103:151625. 2015 by American Society
Use your smartphone
for Reproductive Medicine.)
to scan this QR code
Key Words: Hysteroscopic sterilization, transcervical sterilization, minimally invasive,
and connect to the
contraceptive devices, tubal occlusion
Discuss: You can discuss this article with its authors and with other ASRM members at http://
fertstertforum.com/lachapellecf-hysteroscopic-sterilization-techniques/
Received January 9, 2015; revised and accepted March 12, 2015; published online April 22, 2015.
C.F.l.C. has nothing to disclose. S.V. is a consultant for Bayer HealthCare S.A.S. H.A.M.B. has nothing to
disclose. F.W.J. has nothing to disclose.
C.F.l.C. and S.V. should be considered similar in author order.
Reprint requests: Claire F. la Chapelle, M.D., Albinusdreef 2, Leiden, Zuid Holland 2300 RC, the
Netherlands (E-mail: C.F.la_Chapelle@lumc.nl).
Fertility and Sterility Vol. 103, No. 6, June 2015 0015-0282/$36.00
Copyright 2015 American Society for Reproductive Medicine, Published by Elsevier Inc.
http://dx.doi.org/10.1016/j.fertnstert.2015.03.009
1516
METHODS
This systematic review was conducted according to the
PRISMA guidelines. All longitudinal studies addressing hysteroscopic sterilization were considered for inclusion, both
prospective and retrospective. Studies were included if successful placement rate, safety, effectiveness, or risk factors
for failure of hysteroscopic sterilization were investigated.
VOL. 103 NO. 6 / JUNE 2015
Only original studies with >20 consecutively included participants were selected to allow pooling of data. Descriptive
articles, case series (with nonconsecutively included participants), reviews, surveys, technical reports, and congress
abstracts were excluded. No language restriction was applied.
All types of participants undergoing tubal sterilization by
hysteroscopy were included. Animal studies and studies
wherein electrocoagulation or chemicals (e.g., quinacrine)
were used to obliterate the tubes were excluded.
To assess feasibility we considered successful placement
rate, percentage of conrmed proper placements, and the
occurrence of procedural complications as important outcomes. As effectiveness refers to the ability to prevent
conception, we evaluated the rate of unintended pregnancies
after conrmation of correctly placed devices. Hence we
formulated the following research questions:
What is the probability of a successful bilateral placement
at the rst attempt of a hysteroscopic sterilization?
What percentage of women have a conrmed correct
bilateral placement of the devices 3 months after the
procedure?
What are the risk factors for placement failure of the
devices used for hysteroscopic sterilization?
What are the complications of hysteroscopic sterilization,
and what are the corresponding incidences?
What is the incidence of pregnancy after conrmed
correct bilateral placement?
We dened successful placement rate as the percentage of
women who had successful bilateral procedures in a rst
attempt. There are some differences in the denitions of successful placement applied by the manufacturers. For Ovabloc
the bilateral instillation is immediately followed by a satisfactory X-ray showing adequate lling, continuous from the tip
to the ampulla. For Essure, successful placement is a hysteroscopically veried bilateral correct position of the inserts during the procedure, which is determined by counting the
number of coils protruding in the uterine cavity. For Adiana
successful bilateral placement includes bilateral insertion
and conrmation of placement at 1 week postprocedure using
transvaginal ultrasound.
Conrmed correct placement rate was recorded as the
percentage of women with good results on the 3-month postprocedure conrmation test out of the total number of women
who had a successful placement. There are also differences in
the conrmation tests prescribed by the manufacturers. After
the Ovabloc procedure, the required conrmation test is a second X-ray to evaluate for correct position of the devices. After
Essure procedures, an X-ray or transvaginal ultrasound to
conrm appropriate retention and location of both devices
or conrmed bilateral tubal occlusion on HSG is required.
For Adiana, the conrmation test includes verication of
bilateral occlusion with an HSG. For all techniques, we
excluded successful single placements in patients with a history of salpingectomy, because the higher chance for successful single placement would confound the successful
placement outcome.
1517
RESULTS
The search produced 429 unique references, of which 66 were
considered relevant to the topic based on title and abstract.
Figure 1 shows the ow diagram of the selection process.
Finally, a total of 45 articles were eligible for analyses: six articles concerned Ovabloc, 37 Essure, and two Adiana sterilization. The eligible studies included no randomized controlled
trials (RCTs), 30 prospective, 13 retrospective, one partly
retro- and partly prospective cohort study, and one study
with unclear perspective.
Ovabloc
Characteristics of the included Ovabloc studies are shown in
Supplemental Table 1 (7, 912). A total of 2,039 women
were included in two prospective and four retrospective
studies. The articles were published between 1983 and 1999.
Two studies were multicenter, and four were single-center.
Two articles included cohorts that had overlap with each other
(7, 12). None of the studies reported a potential conict of
interest. The number of participants in each trial ranged
from 115 to 438. The age range was 1846 years. The
exclusion criteria were clearly dened in ve articles. Three
studies included nulliparous women (9, 12, 13). There were
considerable differences in exclusion criteria between
studies. In one study tubal patency was tested with
perfusion of diluted methylene blue dye before instillation.
Women with no tubal patency in one or both tubes were
excluded for an installation attempt (13).
All procedures were performed with a paracervical block.
One study reported premedication of naproxen 12 hours and 2
FIGURE 1
Identified articles based
on search strategy: 429
Not relevant to the topic based
on title or abstract: 363
Retrieved to read full
text article: 66
Articles included: 45
Adiana: 2
Essure: 37
Ovabloc: 6
Flow diagram.
la Chapelle. Sterilization by hysteroscopy. Fertil Steril 2015.
Risk factors for Ovabloc placement failure. Univariate analyses for risk factors were performed in two studies (9, 13).
Van der Leij and Lammes compared 71 failed with 340
successful procedures and found nulliparity (OR, 3.87; 95%
CI, 1.897.92), intrauterine pathology (OR, 4.5; 95% CI,
2.388.51), and an asymmetric uterine cavity (OR, 3.65;
95% CI, 1.508.91) to be associated with failure (13). De
Blok et al. compared Ovabloc sterilizations performed with
SF with those performed with CF hysteroscopies. Procedures
performed with CF hysteroscopy had lower failure rates
owing to failed instillation of silicon in the tubes or
insufcient visualization. The failed procedure rate
decreased from 29% to 12% when CF hysteroscopy was
used (OR, 0.33; 95% CI, 0.120.97) (9).
Essure
The included Essure studies are described in detail in
Supplemental Table 2. A total of 14,126 women were included
in 37 studies: 26 prospective (4, 5, 15-19, 21, 23, 24, 27, 2830, 32, 42, 46-50, 52, 54-58), nine retrospective (20, 22, 25,
26, 31, 33, 34, 51, 53), one partly retro- and partly
prospective (16), and one with unclear relation between
enrollment and occurrence of the outcomes (14). The
articles were published from 2003 to 2012. Ten studies were
multicenter, and 27 were single-center. Nine articles studied
a cohort that overlapped with a cohort in another article:
seven of these were performed in centers in France (1420),
and two in Spain (21, 22). In 13 studies a potential conict
of interest was reported, in four studies it was stated there
was no potential conict, and in 20 studies this remained
unclear.
The number of participants in each trial ranged from 24 to
4,306. The age ranged from 19 to 57 years. The exclusion
criteria were not described in 26 articles, in 11 articles the
exclusion criteria were reported, and three studies (14, 23,
24) referred to the criteria dened in the instructions for
use. The version of the device used was not dened in 29
articles, ESS 305 was used in three articles (19, 24, 25), ESS
205 in one article (26), and the version known as STOP
(selective tubal occlusion procedure) was used in two
articles (4, 5). In two articles both the ESS 205 and 305 (20)
and the ESS 105 and 205 (27) were used. In one study
concomitant procedures were excluded (23), seven studies
included patients whom received concomitant procedures
(1620, 28, 29), and all other studies did not specically
TABLE 1
Feasibility of Ovabloc, Essure, and Adiana.
Technique
Ovabloc
Essure
Adiana
Note: Feasibility includes the success rates for placement at the rst placement attempt and conrmed correct placement assessed with the 3-mo conrmation test. The last column shows the
cumulative number of unintended pregnancies.
la Chapelle. Sterilization by hysteroscopy. Fertil Steril 2015.
1519
FIGURE 2
OVABLOC pregnancies
Study
Proportion
Events Total
Reed (1984)
309
24.1%
24.1%
Blok de (1992)
75
4.0%
4.0%
Loffer (1992)
190
8.1%
8.1%
324
47.7%
47.7%
Ligt -Veneman(1999)
314
16.1%
16.1%
1212
100%
--
--
100%
0.01
0.02
0.03
0.04
Number of pregnancies for included Ovabloc studies. Probabilities are shown with 95% CIs.
la Chapelle. Sterilization by hysteroscopy. Fertil Steril 2015.
FIGURE 3
ESSURE pregnancies
Study
Events Total
Proportion
Andersson (2009)
57
0 [ 0; 0.06]
3.6%
3.6%
Chapa (2011)
125
0 [ 0; 0.03]
3.6%
3.6%
Chern (2005)
67
0 [ 0; 0.05]
3.6%
3.6%
Cooper (2003)
446
0 [ 0; 0.01]
3.6%
3.6%
Duffy (2005)
34
0 [ 0; 0.10]
3.5%
3.5%
Kerin (2003)
198
0 [ 0; 0.02]
3.6%
3.6%
Legendre (2011)
251
0 [ 0; 0.01]
3.6%
3.6%
Litta (2005)
32
0 [ 0; 0.11]
3.5%
3.5%
Mino (2007)
843
0 [ 0; 0.00]
3.6%
3.6%
Panel (2011)
300
0 [ 0; 0.01]
3.6%
3.6%
Povedano (2012)
4 4095
0 [ 0; 0.00]
28.7%
28.7%
Ubeda (2004)
74
0 [ 0; 0.05]
3.6%
3.6%
Veersema (2011)
4 1024
0 [ 0; 0.01]
28.6%
28.6%
Vleugels (2005)
160
0 [ 0; 0.02]
3.6%
3.6%
7706
0 [ 0; 0.00]
100%
--
0 [ 0; 0.00]
--
100%
0.02
0.04
0.06
0.08
0.1
Number of pregnancies for included Essure studies. Probabilities are shown with 95% CIs.
la Chapelle. Sterilization by hysteroscopy. Fertil Steril 2015.
Adiana
The included articles for Adiana both concerned the Evaluation of the Adiana System for Transcervical Sterilization
trial from 2002 through May 2005, a prospective, singlearm, international study, involving 18 investigators at 16
sites (6, 35). A total of 645 women participated in the
study. Women were eligible to participate if they were
1845 years of age, were generally healthy, had
established fertility, and were seeking permanent
contraception. Exclusion criteria included major medical
conditions, use of cortisone or cytostatic medication,
any underlying health condition that would adversely
affect the ability to undergo surgical procedures (e.g.,
cardiovascular conditions), PID, intrauterine conditions
that may affect tubal access (e.g., synechiae), signicant
cervical or uterine pathology, or any condition that might
compromise compliance or long-term study follow-up.
Each participant underwent a complete physical examination, with documentation of normal cervical cytology,
negative testing for STIs, and a negative pregnancy test
to conrm study eligibility. The mean age was 31 years
(range, 2045 years), with a mean parity of 2.2 (range, 0
7). Different analgesic regimes used during the procedure
ranged from topical or local to IV sedation. Three months
postprocedure an HSG was performed to conrm bilateral
occlusion. Thereafter, women were evaluated by ofce
visits at 3, 6, and 9 months and at 1, 2, and 3 years.
Women with an unsuccessful sterilization (n 75) were
excluded from the study or were followed for safety evaluation only.
The assessment of successful placement was clearly
dened. A small number of women were lost to followup for the 3-month HSG (7/611). Of the 570 women who
were able to rely on the sterilization, 97% (n 547),
92% (n 523), and 89% (n 505) were compliant
with the follow-up at 1, 2, and 3 years, respectively. Concerning safety, the method of assessing and recording complications is unclear. Additionally, it remains unclear how
many women unable to rely on Adiana sterilization were
followed for safety evaluation. We found a low risk of
bias for the outcome measurements of successful placement, conrmed correct placement, and incidence of pregnancy and an unclear to high risk of bias for outcome
complications.
Feasibility of Adiana. The results on feasibility and effectiveness are presented in Table 1. Successful bilateral placement
in a rst attempt was achieved in 607 (94%) of 645 women.
In seven women successful placement was achieved in a
second attempt. An HSG was used to conrm reliability in
604 women. In 91% (n 551), bilateral occlusion after a successful rst placement was conrmed 3 months postprocedure (Table 1). Reevaluation of the remaining women by
HSG at 6 months conrmed bilateral occlusion in an additional 19 women. According to the protocol, 611 women
1522
DISCUSSION
Although the rst studies on hysteroscopic sterilization date
back to the turn of the century, and the approach is widely
applied in female sterilization, it is remarkable that the
currently available evidence is still poor. To evaluate the
effectiveness of an intervention, an RCT is the appropriate
design. We did not nd any RCT for hysteroscopic sterilization. When the outcomes of interest are infrequent and/or
far in the future (e.g., 0.5% pregnancies in the rst year poststerilization), RCTs are rarely large and lengthy enough to
accurately measure infrequent outcomes. A prospective
cohort study will facilitate a larger study population and
adequate power to identify signicant differences. In this
review, the available evidence on effectiveness of hysteroscopic sterilization techniques comes from observational
studies. Unfortunately, these studies are lacking sufcient
power and complete and long-term (>10 years) follow-up
data on unintended pregnancies and complications from
placement and long-term complications.
In addition to the methodological quality of the included
studies, another limitation is the inclusion of nine Essure
articles and two Ovabloc articles that probably included
women who may also be included in other included articles.
We could not correct our calculations for this potential overlap. The potential conict of interest in a large portion of the
studies is a third limitation.
Considering feasibility, the 78%98% probability of successful placement at rst attempt, and the 90%100% veried
by a proper conrmation test, all three hysteroscopic sterilization techniques have sufcient success rates. With a low risk
of bias for these outcomes, we consider these rates reliable.
Adiana and Essure have the highest successful placement
rates, 94% and range, 81%98%, respectively, versus
Ovabloc, range, 78%84%. This is explained by differences
in patient selection and different hysteroscopic systems. For
all three techniques, complications during the procedures
were incidentally reported. The reported complications
concerned perforations or expulsions typically related to
incorrect placements. The quality of evidence for the outcome
complications is very low, since the denition and assessment
of this outcome is not clear in the majority of the studies.
The reported incidence of unintended pregnancies after
conrmed successful hysteroscopic sterilization with Adiana
are considered reliable, although this does not apply to the
VOL. 103 NO. 6 / JUNE 2015
Future Perspectives
Since 1988 three methods have become commercially available. Two methods were later withdrawn from the market.
In 2009, reports of disappointing results, technical problems
with the cold storage of the silicon, and a histological study
that could not conrm the claim of reversibility of the techVOL. 103 NO. 6 / JUNE 2015
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1525
SUPPLEMENTAL METHODS
SEARCH:
((((Hysteroscopy[mesh] OR hysteroscop*[tiab] OR uteroscop*[tiab] OR transcervical[tiab])) AND ((sterilization, tubal
[mesh]) OR ((Sterilization, reproductive[MeSH] OR steriliza-
1525.e1
SUPPLEMENTAL FIGURE 1
Risk-of-bias graph. Review authors' judgments about each risk-of-bias item presented across all included Ovabloc studies.
la Chapelle. Sterilization by hysteroscopy. Fertil Steril 2015.
1525.e2
SUPPLEMENTAL FIGURE 2
Risk-of-bias graph. Review authors' judgments about each riskof-bias item presented across all included Essure studies.
la Chapelle. Sterilization by hysteroscopy. Fertil Steril 2015.
1525.e3