Sexual function and quality of life of women adopting the levonorgestrel-releasing intrauterine system (LNG-IUS 13.5 mg) after abortion for unintended pregnancy

Abstract

Purpose: The aim of the study was to investigate the impact of the long-acting reversible contraception (LARC) levonorgestrel-releasing intrauterine system (LNG-IUS 13.5 mg) on sexual function and quality of life (QoL) in women after having undergone abortion for unintended pregnancy.
Methods: In a prospective controlled study, 128 women aged 16–35 years received counseling to adopt LNG-IUS contraception after termination of pregnancy. The Visual Analog Scale (VAS), the Short Form-36 questionnaire (SF-36), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) were used to investigate, respectively, pelvic pain levels, QoL, sexual function and sexual distress of these women at baseline (T0) and at 6 (T1) and 12 (T2) months after LNG-IUS placement.
Results: Sixty-six (51.6%) women adopted a SARC method, mainly because of the cost of the LNG-IUS. They constituted the control group. The study group consisted of 62 (48.4%) women. Improvement of QoL was observed at T1 (p < .05) and T2 (p < .01). Moreover, sexual function improved and dyspareunia decreased over the study period compared to baseline (p < .001). Dysmenorrhea measured by VAS improved at T1 and at T2 (p < .001). The women of the control group did not experience statistically significant changes at T1 and T2 compared to T0 (p = NS).
Conclusions: Women who underwent termination of pregnancy experienced positive changes in QoL and sexual function during LNG-IUS use. These results have to be confirmed in larger studies. However, not all women could adopt the LNG-IUS because of the cost of the contraceptive.

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Sexual function and quality of life of women
adopting the levonorgestrel-releasing intrauterine
system (LNG-IUS 13.5 mg) after abortion for
unintended pregnancy
Salvatore Caruso, Stefano Cianci, Salvatore Giovanni Vitale, Valentina Fava,
Silvia Cutello & Antonio Cianci
To cite this article: Salvatore Caruso, Stefano Cianci, Salvatore Giovanni Vitale, Valentina
Fava, Silvia Cutello & Antonio Cianci (2018): Sexual function and quality of life of women
adopting the levonorgestrel-releasing intrauterine system (LNG-IUS 13.5 mg) after abortion for
unintended pregnancy, The European Journal of Contraception & Reproductive Health Care, DOI:
10.1080/13625187.2018.1433824
To link to this article: https://doi.org/10.1080/13625187.2018.1433824
Published online: 13 Feb 2018.
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ORIGINAL RESEARCH ARTICLE
Sexual function and quality of life of women adopting the
levonorgestrel-releasing intrauterine system (LNG-IUS 13.5 mg) after
abortion for unintended pregnancy
Salvatore Caruso , Stefano Cianci , Salvatore Giovanni Vitale , Valentina Fava, Silvia Cutello and
Antonio Cianci
Department of General Surgery and Medical Surgical Specialties, Gynecological Clinic, Research Group for Sexology, University of
Catania, Catania, Italy
ABSTRACT
Purpose: The aim of the study was to investigate the impact of the long-acting reversible contra-
ception (LARC) levonorgestrel-releasing intrauterine system (LNG-IUS 13.5 mg) on sexual function
and quality of life (QoL) in women after having undergone abortion for unintended pregnancy.
Methods: In a prospective controlled study, 128 women aged 16–35 years received counseling to
adopt LNG-IUS contraception after termination of pregnancy. The Visual Analog Scale (VAS), the
Short Form-36 questionnaire (SF-36), the Female Sexual Function Index (FSFI) and the Female
Sexual Distress Scale (FSDS) were used to investigate, respectively, pelvic pain levels, QoL, sexual
function and sexual distress of these women at baseline (T0) and at 6 (T1) and 12 (T2) months after
LNG-IUS placement.
Results: Sixty-six (51.6%) women adopted a SARC method, mainly because of the cost of the
LNG-IUS. They constituted the control group. The study group consisted of 62 (48.4%) women.
Improvement of QoL was observed at T1 (p<.05) and T2 (p<.01). Moreover, sexual function
improved and dyspareunia decreased over the study period compared to baseline (p<.001).
Dysmenorrhea measured by VAS improved at T1 and at T2 (p<.001). The women of the control
group did not experience statistically significant changes at T1 and T2 compared to T0 (p¼NS).
Conclusions: Women who underwent termination of pregnancy experienced positive changes in
QoL and sexual function during LNG-IUS use. These results have to be confirmed in larger studies.
However, not all women could adopt the LNG-IUS because of the cost of the contraceptive.
ARTICLE HISTORY
Received 13 October 2017
Revised 20 January 2018
Accepted 24 January 2018
Published online 13 February
2018
KEYWORDS
LARC; LNG-IUS; quality of
life; SARC; sexual function;
unplanned pregnancy
Introduction
Current contraceptive counseling aims to improve accept-
ability of a contraceptive not only as a method chosen to
avoid pregnancy, but also as having neutral or positive
effects on women’s general health [1,2].
Combined oral contraceptives (COCs) have become the
most frequently used method of reversible contraception in
many countries [3]. Even if advances have been made in
COCs, including a reduction of the ethinylestradiol dosage
or containing 17b-estradiol, and the production of more
selective progestogens having antiandrogenic activity, or
the route of their administration by patch or vaginal ring
[4], they may still be used incorrectly. This could depend
on being afraid of using hormones, adverse events such
as weight gain, spotting, bleeding, or headache.
Consequently, a woman may abandon her contraceptive,
and discontinuation may be followed by an unintended
pregnancy. Moreover, ineffective use of non-hormonal
contraception, such as an incorrectly used condom or use
of the withdrawal method, is prevalent and constitutes a
major risk factor for unintended pregnancies among sexu-
ally active women [5].
On the other hand, the use of different types of contra-
ceptives may be limited by contraindications towards an
adequate method. World Health Organization (WHO)
guidelines provide guidance for how to use contraceptive
methods safely and effectively [6].
In Europe, the rate of unplanned pregnancies is 45% [7].
Usually, not all women return for post-abortion checkups,
and they could be at risk of further unintended pregnan-
cies. It is important that contraceptive counseling be
offered to a woman during her request for termination of
pregnancy (TOP), informing her of the rapid return of fertil-
ity after a TOP; in fact, ovulation may return as early as
8 days following an abortion [8]. Moreover, authors have
reported that more than 50% of women usually reinitiate
sexual activity within 2 weeks and more than 85% after
8 weeks after TOP [9].
To date, long-acting reversible contraception (LARC)
methods are effective options to offer to a woman with a
history of discontinuation of short-acting reversible (SARC)
methods, such as oral, patch or vaginal combined hormo-
nal contraceptives, or non-hormonal contraceptives, with
the subsequent possibility of another unintended preg-
nancy [10,11].
The aim of this study was to investigate the effectiveness
of a levonorgestrel-releasing intrauterine system (LNG-IUS
13.5 mg, 8 lg daily release rate; Jaydess, Bayer, Pharma AG,
Leverkusen, Germany) on the QoL and sexuality (primary
endpoint) in women who discontinued COC usage or had
used no hormonal contraception after having undergone
CONTACT Salvatore Caruso scaruso@unict.it Gynecological Clinic of the Policlinico Universitario, Via S.Sofia 78, 95124 Catania, Italy
ß2018 The European Society of Contraception and Reproductive Health
THE EUROPEAN JOURNAL OF CONTRACEPTION & REPRODUCTIVE HEALTH CARE, 2018
https://doi.org/10.1080/13625187.2018.1433824

abortion for unintended pregnancy. Moreover, the efficacy of
the LNG-IUS on dysmenorrhea was a secondary endpoint.
Materials and methods
This prospective, non-randomised controlled study was per-
formed at the Family Planning Centre of the Research
Group for Sexology, Department of General Surgery and
Medical Surgical Specialties, School of Medicine, University
of Catania, Italy. The study protocol was approved by the
Institutional Review Board of the Department and con-
formed to the ethical guidelines of the 1975 Declaration of
Helsinki. Informed written consent was obtained from each
woman before entering the study, and they did not receive
any monetary payment. Informed consent was obtained
directly from the women who were 18 years of age.
Parental consent was obtained for teenagers under
18 years.
The time of enrollment was from January 2015 to
October 2015. Exclusion criteria included distortion of the
uterine cavity, dysplasia, previous or current pelvic inflam-
matory disease. All women had ultrasonography 1 week
after abortion, cervix and vagina swabs at the second week
and, at the third week, received the swab results and any
therapy necessary before LNG-IUS placement.
One hundred and twenty-eight women were recom-
mended by the health care professionals to use the LNG-
IUS after TOP. These women constituted the study sample.
Procedures to the IUS insertion and control
The intrauterine system was placed at the fourth week,
medially, and during the first 7 days of the menstrual cycle.
The women were advised to use a barrier method during
the period prior to the IUS placement. Figure 1 shows the
flowchart. Even if IUS placement is recommended at the
time of abortion [11], the choice to do this a month after
abortion depended on the partial expulsion of the device
[12]. In our experience, the partial expulsion was 5% when
we inserted IUS immediately after surgical abortion (per-
sonal unpublished data).
The placement site was pre-medicated with a vaginal
disinfectant solution, and no woman needed oral analgesics
or cervical dilation. A tenaculum with thin tips was used to
reduce the axis of the uterus in 21 (33.9%) women where
the placement was not easy. Ultrasonography followed to
verify the correct placement. On average 30 days after the
LNG-IUS placement and, however, at the end of the next
menstrual period, a clinical evaluation and ultrasonography
were performed on each woman.
Instruments
To define the pelvic pain levels during and after the LNG-
IUS placement, the Visual Analog Scale (VAS) was used [13].
Women were instructed to place a mark on a 0–10 scale, 0
representing absence of pain and 10 indicating unbearable
pain.
QoL and sexuality of the women were assessed with
standardised, validated questionnaires. The Short Form-36
(SF-36) questionnaire was used to assess QoL [14]. The SF-
36 questionnaire contains 36 questions grouped into eight
categories: physical functioning (10 items), physical role
functioning (4 items), bodily pain (2 items), general health
(6 items), vitality (4 items), social functioning (2 items),
emotional role functioning (3 items), and mental health (5
items).
Figure 1. Flowchart.
2 S. CARUSO ET AL.

Each woman underwent a sexual history interview. To
define female sexual dysfunction (FSD), the definition and
classification of the second report of the international con-
sensus development conference on FSD were used [15].
To measure the level of sexual behavior the self-adminis-
tered Female Sexual Function Index (FSFI) validated in the
Italian gynecological population was used [16]. The FSFI
consists of six domains, which include desire (two items),
arousal (four items), lubrication (four items), orgasm (three
items), satisfaction (three items), and pain (three items),
answered on a five-point Likert scale, ranging from 0 (no
sexual activity) or 1 (never/very low) to 5 (always/very
high). A score is calculated for each of the six domains and
the total score is obtained summing all the items. The total
score range is 2–36. A cut-off of 26.55 is usually accepted
for diagnosis of sexual dysfunction. Moreover, for diagnosis
of sexual dysfunction, an essential element is the require-
ment that the condition causes significant personal distress
for the woman. Therefore, the Female Sexual Distress Scale
(FSDS) was used [17]. The FSDS consists of 12 items with a
maximum score of 48. An FSDS score of 15 corresponds
to clinically significant distress. We considered women with
an FSFI score of <26.55 to be affected by sexual dysfunc-
tion if they also had an FSDS score of 15.
Furthermore, each woman received a diary to record
daily sexual activity covering behaviors from self-stimula-
tion to arousal with partner and actual intercourse; more-
over, the incidence of adverse events of the study group,
the characteristics of withdrawal and intracyclic bleeding
were also recorded.
At baseline (T0), and at the sixth month (first follow-
up ¼T1), and the 12th month (second follow-up ¼T2) each
woman of both groups completed all the questionnaires.
At the end of the study, the women of the study group
were asked to rate their satisfaction by using the system of
very satisfied, somewhat satisfied, neither satisfied nor dis-
satisfied, dissatisfied, or very dissatisfied.
Statistical analysis
For comparisons of the values obtained from the FSFI items
between baseline and both follow-ups, the non-parametric
Wilcoxon rank-sum test with z-values was used. Paired
Student’st-test was used to compare the values obtained
at baseline with those of both follow-ups from the SF-36
domains, the VAS scores, the FSDS and the frequency of
sexual activity. One-way analysis of variance was used to
compare the demographic and clinical data between the
groups. Scores are presented as mean ± standard deviation
(SD). The result was statistically significant when p<.05.
Statistical analysis was carried out using a software package
for Windows 95
TM
(Glantz SA, Primer of Biostatistics,
McGraw-Hill Inc., New York, 1997).
Results
After contraception counseling, 66 (51.5%) women aged
17–34 years (mean ± SD, 26 ± 5) chose to adopt an SARC
method. Their choice mainly depended on the cost (e173)
of the LNG-IUS. They were invited to participate in the
study as a control group. The study group consisted of
62 (48.5%) women aged 16–35 years (mean ± SD, 25 ± 5).
Table 1 shows the demographic characteristics of the sam-
ple. Of all the women enrolled, 44 (34.4%) had used a hor-
monal contraceptive and reported to have had no adverse
Table 1. Baseline demographic characteristics.
Characteristics Study group (n¼62) Control group (n¼66) p
Age range, years 16–35 17–34 NS
Age, mean ± SD, years 26 ± 5 25 ± 5 NS
BMI, mean ± SD, kg/m
2
25.3 ± 3.1 26.1 ± 2.4 NS
Cycle length, mean ± SD, days 27 ± 3.5 27.3 ± 2.8
Length of menses, mean± SD, days 4 ± 1.8 4.5 ± 1.7 NS
Education level, n(%)
High 3 (4.8) 4 (6.6) NS
Medium 7 (11.3) 6 (9.1) NS
Low 52 (83.9) 56 (84.9) NS
Cigarette smoking, n(%)
Smoker 22 (35.5) 24 (36.4) NS
Never smoked 10 (16.2) 11 (16.7) NS
Past smoker 30 (48.3) 31 (46.9) NS
Social status, n(%)
Married 18 (29.1) 20 (30.3) NS
Cohabiting 24(38.7) 24 (36.4) NS
Single 20 (32.2) 22 (33.3) NS
Parity, n(%)
One 47 (75.8) 48 (72.7) NS
Two 9 (14.5) 10 (15.2) NS
Three 6 (9.7) 8 (12.1) NS
Previous elective abortion, n(%)
One 31 (50) 34 (51.5) NS
Two 15 (24.2) 14 (21.2) NS
Three 16 (28.8) 18 (27.3) NS
Hormonal contraception in the past, n(%)
Oral pill 20 (32.4) 17 (25.9) <.05
Vaginal ring 8 (12.9) 9 (13.6) NS
Non-hormonal contraception, n(%)
None 21 (33.8) 25 (37.8) <.05
Condom 13 (20.9) 15 (22.7) NS
Systolic blood pressure, mean± SD, mmHg 103.5 ± 10.8 108.6 ± 9.8 NS
Diastolic blood pressure, mean± SD, mmHg 62.7 ± 7.1 61.5 ± 7.8 NS
Heart rate, mean ± SD, beats/min 67.3 ± 9.5 70.1 ± 11.5 NS
THE EUROPEAN JOURNAL OF CONTRACEPTION & REPRODUCTIVE HEALTH CARE 3

events. On the other hand, 84 (65.6%) women had used
non-hormonal contraception and showed no contraindica-
tions to hormonal contraception usage. The women of
both groups had undergone one [65 (50.8%)], two [29
(22.6%)] or three [34 (26.6%)] elective abortions for unin-
tended pregnancy.
There were 33 (25.8%) women who were positive for
vaginal infection: Escherichia coli [8 (6.3%)], Enterococcus
faecalis [12 (9.3%)] and Vulvovaginal candidiasis [19
(14.9%)]. They were eligible for enrollment when the infec-
tion was successfully treated.
Particularly, the LNG-IUS was placed at the third [13
(20.9%)], fourth [17 (27.5%)], fifth [19 (30.7%)] or sixth [13
(20.9%)] day of the cycle (baseline ¼T0), on the basis of
quantity and length of the menses, and at the first inser-
tion attempt. During the placement of the LNG-IUS, 42
(67.7%), 15 (24.2%) and 5 (8.1%) women reported no pain,
mild pain and moderate pain, respectively. Mild or moder-
ate pain was reported by women who needed the use of a
tenaculum to place the intrauterine system (20/21, 95.2%).
There were no uterine perforations.
Among the women of the control group, 28 (42.5%)
adopted oral contraceptives, 15 (22.7%) vaginal ring, and
23 (34.8%) non-hormonal contraception. At T1 and T2, 51
(77.3%) and 42 (63.6%) underwent follow-up evaluations,
respectively.
Figure 2(A) shows the QoL of women before and during
the use of the LNG-IUS. Improvement of both the somatic
and mental categories was observed at T1 (p<.05). The
improvement was more evident at T2 (p<.01), particularly
for pain symptoms (p<.001). Figure 2(B) shows the QoL of
women of the control group. No improvement was
observed in both follow-ups versus T0 (p¼NS).
Table 2 shows the intergroup statistical comparison ana-
lysis of the QoL between T0, T1 and T2. At T0, SF-36 scores
of both the groups were similar (p¼NS). On the contrary,
at T1 (p<.001) and at T2 (p<.001) women of the study
group had a better QoL than those of the control group.
Figure 2. QoL (SF-36 score) of women using LNG-IUS 13.5 mg system (A) and on SARC methods (B).
4 S. CARUSO ET AL.

Table 3(A) shows the changes of sexual function and
sexual distress of women of the study group. At T1 and T2,
the FSFI and FSDS scores improved compared to the base-
line (p<.001). It is interesting to note that there was no
difference in the various items of sexual function between
T1 and T2 values, with the exception of dyspareunia that
further improved at T2 (T2 versus T1, p<.001). Women of
the control group did not undergo changes in FSFI and
FSDS scores at T1 with respect to T0 (p¼NS). Even if an
improvement of both the FSFI and FSDS scores was
observed at T2, they remained within the dysfunctional
range (Table 3(B)).
Table 4 shows the intergroup statistical comparison ana-
lysis of sexual function (FSFI) and sexual distress (FSDS)
scores at T0, T1 and T2. There was no statistical difference
at T0 between the study group and the control group.
However, at T1 and at T2 both FSFI and FSDS scores
improved in the study group with respect to the control
group (p<.001).
From the diary, the frequency of sexual activity was
3.1 ± 0.5 and 2.9 ± 0.7 times monthly at T0 (p¼.06) in the
study and the control group, respectively; it improved in
the study group at T1 (3.9 ± 0.5; p<.001) and at T2
(4.1 ± 0.8; p<.001). However, the frequency of sexual activ-
ity at T2 was similar to that recorded at T1 (p¼.11). The
frequency of sexual activity of the control group did not
undergo statistically significant changes, in fact, it was
3.1 ± 0.4 at T1 (p¼.07) and 3.2 ± 1.2 (p¼.1).
Interestingly, the percentage of discontinuation was
8.1%; in fact, five women requested the removal of the
system within the first 3 months due to spotting that was
unresponsive to medical therapy. Consequently, 57 (91.9%)
women completed the study. Moreover, mild spotting was
reported by four other women (6.5%) during the first
2 months and 5 (8.1%) during the third month of use,
which did not, however, induce discontinuation.
Furthermore, 11 (19.3%) women had reduced menstrual
flow, while none of the woman had amenorrhea. No preg-
nancy occurred at 6 and 12 months of use and no pelvic
infection was diagnosed. By ultrasonography, ovarian cysts
(mean diameter 32 ± 14 mm) were observed in 6 (10.5%)
and in 4 (7.1%) women at 6 and 12 months, respectively.
There was no expulsion or partial expulsion into the cer-
vical canal.
Figure 3 shows dysmenorrhea levels measured by VAS.
At T0 the women of the study group had moderate-to-
severe pain (7 ± 2.2); dysmenorrhea improved at T1 (4 ± 1.8;
p<.001) and at T2 (3 ± 1.7; p<.001).
Finally, 49 (85.9%), 5 (8.8%) and 3 (5.3%) women rated
their satisfaction using the LNG-IUS as very satisfied, some-
what satisfied, neither satisfied nor dissatisfied, respectively.
Discussion
Findings and interpretation
The study investigated the QoL and sexuality of women
using the LNG-IUS 13.5 mg adopted after having undergone
abortion for unintended pregnancy. The women had an
improvement of all the QoL aspects after 6 months of the
Table 2. Intergroup statistical comparison analysis of QoL scores between baseline (T0), 6th month (T1) and 12th month (T2).
T0, study (n¼62) versus control
(n¼66) group
T1, study (n¼57) versus control
(n¼51) group
T2, study (n¼57) versus control
(n¼42) group
SF-36 QoL scores t95% CI pt 95% CI pt 95% CI p
Physical function 0.00 1.59 to 1.59 1 8.30 8.30 to 9.91 <.001 4.89 8.92 to 21.08 <.001
Physical role 1.7 4.31 to 0.31 .09 7.74 6.69 to 11.3 <.001 4.57 7.92 to 20.08 <.001
Body pain 1.88 6.15 to 0.15 .06 77.82 14.62 to 15.3 <.001 9.58 30.9 to 47.09 <.001
General health 0.62 4.15 to 2.15 .5 13.52 15.36 to 20.6 <.001 7.62 22.9 to 39.09 <.001
Vitality 1.88 0.15 to 6.15 .06 7.51 7.36 to 12.6 <.001 4.42 9.92 to 26.09 <.001
Mental health 0.62 5.15 to 2.15 .5 8.26 8.36 to 13.6 <.001 4.91 11.93 to 28.09 <.001
Social function 1.88 0.15 to 6.15 .06 9.94 11.21 to 16.7 <.001 3.93 7.92 to 24.09 <.001
Emotional role 1.25 1.15 to 5.15 .2 7.10 7.21 to 12.7 <.001 5.9 15.9 to 32.09 <.001
DF between groups ¼126 DF between groups ¼106 DF between groups ¼97
DF: degrees of freedom; CI: confidence interval; t: test of analysis of variance.
Table 3. Sexual function (FSFI) and Sexual distress (FSDS) of women using LNG IUS 13.5 mg system (A) and on SARC methods (B).
(A)
FSFI items T0 (n= 62) T1 (n= 57) T2 (n= 57) p-value T1 versus T0 p-value T2 versus T0 p-value T2 versus T1
Desire 3.4 ± 1.3 4.3 ± 1.2 4.6 ± 1.1 .002 .001 NS
Arousal 3.1 ± 1.1 4.6 ± 1.2 4.8 ± 1.2 .001 .001 NS
Lubrication 3.1 ± 1.2 4.2 ± 1.1 4.5 ± 1.3 .001 .001 NS
Orgasm 3.3 ± 1.1 4.4 ± 1.3 4.7 ± 1.2 .001 .001 NS
Satisfaction 3.2 ± 1.1 4.5 ± 1.4 4.8 ± 1.1 .001 .001 NS
Dyspareunia 3.4 ± 1.2 4.5 ± 1.4 5.5 ± 1.5 .001 .001 .001
FSFI Total score 19.5 ± 2.5 26.7 ± 2.7 28.9 ± 2.5 .001 .001 .001
FSDS score 19.3 ± 1.4 11.4 ± 1.8 10.3 ± 2.2 .001 .001 .004
(B)
FSFI items T0 (n= 66) T1 (n= 51) T2 (n= 42) p-value T1 versus T0 p-value T2 versus T0 p-value T2 versus T1
Desire 3.2 ± 1.2 3.3 ± 1.5 3.4 ± 1.1 .68 .38 .7
Arousal 3.2 ± 1.2 3.3 ± 1.1 3.5 ± 1.2 .06 .2 .4
Lubrication 3.3 ± 1.1 3.4 ± 1.2 3.5 ± 1.3 .33 .39 .7
Orgasm 3.1 ± 1.3 3.4 ± 1.2 3.6 ± 1.2 .18 .04 NS
Satisfaction 3.3 ± 1.3 3.4 ± 1.3 3.6 ± 1.1 .39 .2 .4
Dyspareunia 3.3 ± 1.5 3.5 ± 1.2 3.5 ± 1.5 .42 .5 1
FSFI Total score 19.4 ± 2.6 20.3 ± 2.1 21.3 ± 2.2 .06 .003 .02
FSDS score 19.3 ± 2.8 18.4 ± 2.9 15.3 ± 2.2 .09 .001 .004
THE EUROPEAN JOURNAL OF CONTRACEPTION & REPRODUCTIVE HEALTH CARE 5

LNG-IUS placement, and the improvement was more evi-
dent after 12 months. Moreover, the women reported
improvements in all aspects of sexuality during the first
6 months and the benefits were maintained at 12 months,
except for dyspareunia that improved further. In parallel,
the frequency of sexual activity increased. In addition, dys-
menorrhea decreased during the LNG-IUS usage. These
benefits were not observed in the women of the control
group on SARC or on non-hormonal contraception.
Interestingly, 10 (15.2%) women on non-hormonal meth-
ods had unintended pregnancy before the 6-month evalu-
ation. Moreover, 14 (21.2%) women had unplanned
pregnancy between 6 and 12 months after TOP; of these
five (7.6%) had discontinued hormonal contraception and
nine (13.6%) had been on non-hormonal methods. All
women (24, 36.4%) asked for a termination. This is an
aspect to be taken into account when monitoring women
on SARC with previous unwanted pregnancies. The adher-
ence to hormonal contraception has to be strictly moni-
tored and an appropriate counseling has to be adopted to
avoid discontinuation.
Strengths and weaknesses of the study
The strength of the study was the contraceptive counseling
adopted as an integrated part of the abortion services to
help women avoid future unintended pregnancies and risk
of abortion and impairment of QoL and sexuality. A limit of
this study was the small number of women studied; this
mainly depended on the cost of the LNG-IUS. In fact, 40.4%
of women invited to participate in the study chose other
methods, including those that they had previously used,
though not correctly, causing unplanned pregnancy.
Unfortunately, some of them had a further unintended
pregnancy.
Differences in results and conclusion in relation to
other studies
Authors reported similar data to ours [18–20], or no change
[21], or negative interference of LNG-IUS on sexuality
[22,23]. Mainly, these discrepancies in the results of the
aforementioned studies could depend on the characteristics
of the enrolled participants and on the aim of the studies;
moreover, all these studies used a LNG-IUS (Mirena) differ-
ent from the one we adopted (Jaydess) in terms of pharma-
cological properties (total LNG 52 mg/20 lg daily release
rate versus total LNG 13.5 mg/14 lg daily release rate, ours),
and physical dimensions (height/breadth, 32/32 mm versus
30/28 mm ours, respectively). Finally, a recent study with
healthy women that were using Jaydess reported no
change of QoL and sexual life at the 12-month follow-up
[24]. Moreover, some authors have reported high levels of
satisfaction of women on LARC who previously had unin-
tended pregnancy by using SARC [25] as well as a better
QoL [26]. In our current study, 94.7% of women rated their
satisfaction using the LNG-IUS as very satisfied/somewhat
satisfied.
Recently, some authors reported an association between
hormonal contraceptive usage and changes of mood and
depression, with consequent antidepressant usage, espe-
cially among adolescences [27]. Progestins are able to
induce GABA activity provoking negative mood [28]; more-
over, by increasing monoamine oxidase, serotonin concen-
trations can be reduced, inducing depression [29]. The
above effects could cause discontinuation of hormonal
contraception [30]. Women on LNG-IUS can also experience
a relative risk of a first use of antidepressants of 1.4 [27].
However, currently there is no data about depression in
women who are on Jaydess. In our study, no woman
reported negative changes in mood. If that were the case,
they could have a negative influence on QoL and sexuality.
The LNG-IUS should be inserted at the time of abortion,
as recommended by the European Society of Contraception
Expert Group on Abortion [11]. Our choice to do this
1 month after abortion depended on the partial expulsion
of the IUS when it was inserted immediately after surgical
abortion [12]. In fact, no expulsion was observed over the
current study period. However, women were advised to use
a barrier method during the period prior to the LNG-IUS
placement.
In our study, counseling was carried out over an
extended period of time: each woman met a counselor on
average four times before the LNG-IUS placement (Figure 1).
The time spent to educate women about correct adoption
and usage of contraception and to inform them on the effect
and safety of the LNG-IUS could justify the high compliance to
the method over the 12-month study. Except for the discon-
tinuation of five (8.1%) women due to spotting that was
Table 4. Intergroup statistical comparison analysis of sexual function (FSFI) and sexual distress (FSDS) scores between baseline (T0), 6th month (T1) and
12th month (T2).
T0, study (n¼62) versus control
(n¼66) group
T1, study (n¼57) versus control
(n¼51) group
T2, study (n¼57) versus control
(n¼42) group
Quality of sexual life t95% CI pt 95% CI pt 95% CI p
FSFI 0.22 1.79 to 0.99 .8 13.63 5.46 to 7.33 <.001 15.71 6.64 to 8.56 <.001
FSDS 0.00 0.78 to 0.78 1 15.24 7.91 to 6.08 <.001 11.17 5.88 to 4.11 <.001
DF between groups ¼126 DF between groups ¼106 DF between groups ¼97
DF: degrees of freedom; CI: confidence interval; t: test of analysis of variance.
Figure 3. Dysmenorrhea levels measured by VAS before and during the LNG-
IUS 13.5 mg usage.
6 S. CARUSO ET AL.

unresponsive to medical therapy, all women respected the
appointments until the end of the study.
Relevance of the findings: implications for clinicians
and policymakers
Today, strategies for a better contraception should be taken
into consideration to improve a woman’s health, such as
decreasing drop-out, increasing the time using effective
methods, and/or switching from less safe to safer methods
[31]. In fact, the risk of discontinuation and/or change of
contraceptive usage leads to high unplanned pregnancy
rates [32].
We have learned not to expect one contraceptive to be
the solution to all problems. The concept that all women
are different and do not all use contraceptives correctly has
to be emphasised; in fact, we are going into an era where
the concept of tailoring a contraceptive to a particular
woman has to be adopted [2]. Thus, the first step in pre-
scribing a contraceptive is to understand the needs of the
subject and to investigate her current concept of health
[33]. Moreover, particular attention should be given to the
educational aspects during contraceptive counseling to a
woman at risk of unintended pregnancy [34]. Because
many women resume sexual activity soon after an abortion,
they should be advised that ovulation may resume as early
as 8 days after abortion. In fact, sexual desire often arises
during the pre-ovulatory period induced by the increase in
endogenous androgens, and usually it is unconsciously
uncontrolled [35].
LARCs, including the LNG-IUS, have been shown to be
the most effective contraceptive methods to help women
prevent unintended pregnancy following an abortion [36].
Immediate LARC placement has been associated with lower
rates of repeat pregnancy and repeat abortions than the
rates with other contraceptives [37,38]. In fact, women on
typical use of SARC methods have a wider range of 12-
month failure rates than those using LARC methods.
Usually, the pregnancy rate is five pregnancies per 100
woman-years among pill, patch, and ring users as com-
pared with 0.3 pregnancies per 100 woman-years among
LARC users [39].
Unanswered questions and future research
Easy access to LARCs could be the correct strategy to fur-
ther decrease the rate of unintended pregnancies [40].
However, incorrect counseling [41], cost of this method and
low reimbursement for LARC services [42], or a shortage of
trained providers [43] and a lack of immediate LARC access
at the clinical site where the women aborted [44] are sev-
eral barriers for reducing unintended pregnancy.
Countries where unintended pregnancy is considered a
real public health problem and contraceptive strategies are
adopted, mainly LARC usage, a decrease in the rate of
unintended pregnancy is observed [39,41]. We think that
the Ministry of Health, in addition to ensuring access to
abortion services, should ensure women at risk of
unwanted pregnancy or on a low income, can obtain free
contraception.
Conclusions
Women who underwent TOP experienced positive changes
in QoL, and sexual function during LARC use. On the other
hand, women on atypical usage of SARC or on non-hormo-
nal methods may risk unintended pregnancy. These women
usually choose SARC or non-hormonal methods because of
the cost of the LARC.
Acknowledgements
We wish to thank the Scientific Bureau of the University of Catania for
language support.
Disclosure statement
The authors report no conflicts of interest. The authors alone are
responsible for the content and the writing of this article.
ORCID
Salvatore Caruso http://orcid.org/0000-0002-1387-0932
Stefano Cianci http://orcid.org/0000-0002-0548-9891
Salvatore Giovanni Vitale http://orcid.org/0000-0001-6871-6097
Antonio Cianci http://orcid.org/0000-0003-2758-3413
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