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Objective: To determine whether hysteroscopic myomectomy for submucous fibroids in women with
unexplained primary infertility achieved better pregnancy rates than no intervention.
Design: Prospective randomized matched control trial.
Setting: Tertiary university fertility care unit.
Patient(s): From January 1999 to February 2006, a total of 215 women with unexplained primary infertility
and with ultrasonographically diagnosed submucous myomas as the sole cause for fertility failure were
recruited. Intervention(s): Women were randomly allocated to one of two pretreatment groups matched by
age. Hystero- scopic myomectomy was performed in the study group (n 101). Diagnostic hysteroscopy and
myoma biopsy was performed in the control group (n 103). No fertility therapy was given for either group.
Main Outcome Measure(s): Clinical pregnancy rates according to patient and myoma characteristics.
Result(s): The baseline characteristics of both patients and submucous myomas were comparable. Among
patients with complete follow-up, a total of 93 (45.6%) pregnancies occured64 (63.4%) in the study group
and 29 (28.2%) in the control group. Women in the study group had a better possibility of becoming pregnant
after hysteroscopic myomectomy with a relative risk of 2.1 (95% confidence interval, 1.52.9). No difference in
preg- nancy rates was observed according to size, number, and location of myomas in both groups. However,
fertility rates appeared to increase after hysteroscopic myomectomy of type 0 and type I myomas (P < 0.05). In
contrast, for the subgroup of patients with type II myomas, no difference in fertility rates were noted.
Conclusion(s): Hysteroscopic myomectomy for submucous fibroids in women with unexplained primary infertility is effective in achieving a better pregnancy rate. We think that a multicenter study should be conducted
before evaluating the impact of submucous myoma characteristics on fertility outcome. (Fertil Steril
2010;94:7249.
2010 by American Society for Reproductive Medicine.)
Key Words: Submucous myoma, hysteroscopic myomectomy, infertility
724
0015-0282/$36.00
doi:10.1016/j.fertnstert.2009.03.075
polyps).
After a detailed history and thorough clinical examination,
all of the patients received a complete infertility workup
Shokeir et al.
Statistical Analysis
Subjects were randomized into one of two groups in a 1:1 ratio and matched by age using a restricted randomization. A
TABLE 1
Baseline patients and submucous myoma characteristics (n [ 204).
Myomectomy
Study (n [ 101)
Age (y), mean SD
Follow-up (mo), mean SD
Duration of infertility (y), %
R3
<3
Myoma size (mm), %
<5
510
1120
>20
Myoma number, %
1
R2
Myoma type, %
0
I
II
Myoma location, %
Fundal
Lower uterine segment
Cervical
No myomectomy
Control (n [ 103)
30.8 4.1
9.4 2.5
30.9 4.4
8.8 2.4
15.0
27.7
14.0
31.0
24.8
31.7
25.7
17.8
32.0
29.1
22.1
20.4
89.1
10.9
90.3
9.7
56.4
27.7
15.8
58.2
28.2
13.4
59.4
41.0
0.0
63.1
36.9
0.0
P value
NS
NS
NS
NS
NS
NS
NS
DISCUSSION
To our knowledge there are no randomized, control trials
ex- amining fertility outcome after hysteroscopic
myomectomy in patients with unexplained primary
infertility. Retrospec- tive and case control studies
are
associated
TABLE 2
Pregnancy rates according to the characteristics of submucous myomas.
Pregnancy rates
Myoma characteristic
Size (mm), %
<5
510
1120
>20
Number, %
1
R2
Type, %
0
I
II
Location, %
Fundal
Lower uterine segment
Myomectomy
No myomectomy
Study (n [ 101)
Control (n [ 103)
68.0
56.2
61.5
61.1
69.6
53.3
58.3
61.5
44.4
36.4
40.9
30.0
57.9
35.7
31.3
33.3
17.2
29.0
50.0
41.5
53.8
42.1
P value
NS
NS
myomectomy according to the characteristics of the submucous myomas and also the association with intramural fibroids. They found no difference in pregnancy and delivery
rates according to the size and location of submucous myomas. The authors suggest that fertility after hysteroscopic
myomectomy depends mainly on the number of submucous
myomas resected and the association with intramural fibroids. However, their analyses included mixed patients of
variable age groups and different types of infertility. In
the present prospective study, the data suggest that
restoration of reproductive ability among patients with
unexplained primary infertility is found to be unrelated to
myoma size, number, and location, although it is wellknown that such morphologic factors of submucous
myomas are important for the occurrence of repeated
pregnancy losses (1519). In contrast, Varasteh et al. (12)
in his retrospective study in- cluded a control group of
infertile women with a normal uter- ine cavity at
hysteroscopy, and showed a significant benefit of removing
submucous myomas of >2 cm in size. Fernandez et al.
(13), again using a retrospective series, also described
better pregnancy rates after removal of larger myomas,
although the difference was not statistically significant, suggesting a space-occupying lesion mechanism for infertility.
In the current study, submucous myoma type in relation
to pregnancy rate has been evaluated. In this trial, fertility
rates appear to increase after hysteroscopic myomectomy
of type 0 and type I myomas (P < 0.05). However, for the
subgroup of patients with type II myomas, no difference in
fertility was observed compared with controls. These results
are in accor-
NS
<0.001
<0.001
NS
NS
be involved, such as an impairment of implantation subsequent to endometrial alterations. We think that the extent of
endometrial alterations subsequent to the resection depends
on the size, number, type and location of submucous
myomas resected. This suggestion is supported with
evidence from several studies evaluating the effect of
myoma uteri on the pregnancy rate after assisted
reproductive technique (ART). Use of ART provides a
unique setting because factors such as mechanical factors,
greater distance for the gametes to travel, position of the
cervix, or menometrorrhagia can be ex- cluded as possible
causes for infertility associated with this condition. Stovall
et al. (19) showed that even after patients with submucosal
fibroids are excluded, the presence of fibroids reduces the
efficacy of ART. Eldar-Geva et al. (18) compared 106
ART cycles in patients with uterine fibroids with 318 ART
cycles in age-matched patients without uterine fibroids and
concluded that implantation and pregnancy rates were
significantly lower in patients with intramural or submucosal myomas, even in those with no deformation of the
uterine cavity. Therefore, if women with unexplained primary infertility have a better chance of conception after
hys- teroscopic myomectomy and if the main factors in
treatment success are patient age and duration of infertility
as stated by other authors (16), this conservative surgery
should not be postponed for too long.
A recent systematic review and metaanalysis (4) has been
suggested that different types of fibroids may affect
reproduc- tive outcome to a different extent, and removal of
submucous fibroids may be indicated in infertile women
in whom no other factor has been identified. Our
prospective data support these guidelines and provide some
information on the repro- ductive potentials of selected
women who have undergone hysteroscopic myomectomy
for submucous myomas. If we combine the data from our
first prospective control study with data from previously
published ones, we then consider it worthwhile to perform
a hysteroscopic myomectomy in an infertile woman with
otherwise unexplained infertility whose only known
problem is the presence of a submucous myoma.
Although vaginal delivery can be safe after hysteroscopic
myomectomy, and uterine rupture has never been reported
following this procedure, the obstetric management should
be extremely careful (2). Many investigators believe that
cesarean section as a mode of delivery is the best whenever
managing type I or type II submucous myomas
hysteroscopi- cally (12, 16).
In conclusion, pregnancy rates seem to be relatively good
after hysteroscopic myomectomy in women with otherwise
unexplained primary infertility. Ideally, to evaluate the
efficacy of this technique and the fertility outcome after
hys-
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