Levonorgestrel-releasing Intrauterine System Insertion Research Articles

Perimenopausal abnormal uterine bleeding

Abnormal uterine bleeding is a very frequent symptom in the perimenopause. The causes are numerous ranging from physiological reactions due to decreasing/instable ovarian function to premalignant and malignant conditions. Benign findings such as endometrial polyps and myomas are increasing with age, leading to more abnormal uterine bleeding in the perimenopause. Cervical and vaginal causes of abnormal uterine bleeding should also be excluded by speculum examination. Sexually transmitted diseases should be ruled out in the perimenopausal women in new relationships. Measurement of hemoglobine, human chorion gonadotropine and thyreoid hormones are relevant in selected cases. Transvaginal ultrasound is the primary diagnostic tool in perimenopausal abnormal uterine bleeding. Saline or gel contrast sonohysterography improves the diagnostic accuracy. Based on the findings by ultrasound, more invasive procedures such as blind endometrial biopsy or hysteroscopy can be planned. Once premalignant and malignant causes are excluded, the necessity for treatment can be evaluated in collaboration with the individual woman. Severe heavy menstrual bleeding causing anaemia will need immediate treatment. In less severe cases and in intermenstrual bleeding expectant management can be considered. Hormonal medical treatment e.g., progestins or insertion of levonorgestrel-releasing intrauterine system (LNG-IUS) is a possibility in case of anovulatory bleeding interfering with the quality of life. The amount of bleeding can be reduced both by antifibrinolytic and non-steroidal anti-inflammatory drugs and LNG-IUS. In case of focal intrauterine lesions, such as endometrial polyps or submucous myomas, operative hysteroscopic procedures are warranted in the treatment of abnormal uterine bleeding. Other minimally invasive procedures, such as endometrial ablation or endometrial resection, is a good choice in selected cases, but some women will need a hysterectomy as a definite treatment of abnormal uterine bleeding in perimenopause.

Levonorgestrel-releasing intrauterine system effects on metabolic variables in PCOS

Background We aimed to determine and compare the reproductive hormone level and metabolic of patients with polycystic ovary syndrome (PCOS) when treated with a levonorgestrel-releasing intrauterine system (LNG-IUS). Objectives Sixty-four women with PCOS (Group A) and sixty-six healthy women inserted with a LNG-IUS for conception (Group B) were recruited from the Department of Obstetrics and Gynecology in Jinhua Hospital Zhejiang University School of Medicine. Method We compared the general characteristics of the cases between the two groups, including age, body mass index (BMI), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), abdominal circumference (AC) and waist circumference (WC). Each patient was evaluated by transvaginal ultrasonography (TVS) to determine the number of oocytes and ovarian volume, and the intima-media thickness (IMT) of the common carotid artery was measured on an ECG image from the left common carotid artery before and six months, 12 months and 24 months after patients were inserted with the LNG-IUS. Hormone levels (follicle stimulating hormone, luteinizing hormone, serum estradiol and total testosterone), serum insulin, sex hormone binding globulin (SHBG), total cholesterol (TC), high density lipoprotein (HDL), and triglyceride (TG), were evaluated before and six months, 12 months and 24 months after patients were inserted with an LNG-IUS. The levels of testosterone (T) in the non-HA (hyperandrogenemia) group and HA group in PCOS group were compared with the baseline. We also compared cases without insulin resistance in the PCOS group with their baseline. Results Prior to LNG-IUS insertion, the PCOS group had significantly higher total testosterone levels (p < 0.05), lower HDL levels (p < 0.05), and a greater ovarian volume (p < 0.05) than the control group. Compared to baseline values, there was a significant increase in fasting glycemia at six months after LNG-IUS insertion (p < 0.05). Mean ovarian volume was significantly smaller than the volume prior to LNG-IUS insertion (p < 0.05); LDL and TC were significantly reduced when compared to baseline evaluation in the PCOS group. The remaining variables did not differ significantly during the 24 months follow-up period. The control group did not show any significant changes when compared to the period before LNG-IUS insertion. When the groups were compared after the 24-month follow-up, WC, AC, FSH, LH, T, SHBG, HDL, FINs, FAI and ovarian volume were significantly different when compared between the two groups (p < 0.05) . Conclusion The LNG-IUS is an effective and safe non-surgical device and the use of this system for 24 months did not result in significant changes in the clinical and metabolic variables in women with PCOS and healthy control females.

The role of levonorgestrel-releasing intrauterine system for recurrence prevention after conservative surgery among patients with coexistent ovarian endometrioma and diffuse adenomyosis: A retrospective case control study with long-term follow up.

When ovarian endometrioma coexist with adenomyosis, the risk of postoperative recurrence increased. How is the effect of levonorgestrel-releasing intrauterine system (LNG-IUS) on symptomatic recurrence for those patients was unknown. This study retrospectively analyzed 119 women with coexistent endometrioma and diffuse adenomyosis who received laparoscopic excision of pelvic endometriosis from January 2009 to April 2013. Women were categorized into two groups: intervention group with LNG-IUS and control group with expectant observation after surgery. Data were compared in terms of preoperative history, laboratory and intraoperative findings, and clinical outcomes during follow-up, including pain regression, changes in uterine volume and recurrence. During a median 79 months (range, 6-107) of follow-up, patients with LNG-IUS experienced a significantly lower symptomatic recurrence of either ovarian endometrioma or dysmenorrhea (11.1% vs. 31.1%, p=0.013), compared with women under expectant observation by Kaplan-Meier survival analysis (χ2=5.448, p=0.020) and Cox univariate assessment (hazard ratio of 0.336, 95% confidence interval 0.128-0.885, p=0.027). Patients treated with LNG-IUS demonstrated a more prominent reduction in uterine volume (-14.1±20.9vs. 8.7±48.8, p=0.003) and higher percentage of complete pain remission (95.6% vs. 86.5%). For multivariate analysis, use of LNG-IUS (aHR 0.159, 95%CI 0.033-0.760, p=0.021) and severity of dysmenorrhea (aHR 4.238, 95%CI 1.191-15.082, p=0.026) were two independent factors associated with overall recurrence. Postoperative insertion of LNG-IUS may prevent recurrence in symptomatic women with comorbidity of ovarian endometrioma and diffuse adenomyosis.

Operative Hysteroscopy Versus Levonorgestrel-Releasing Intrauterine System (LNG-IUS) Insertion: A Prospective Observational Study on the Effect of Surgical and Medical Treatments on Sexual Functions in Women With Abnormal Uterine Bleeding.

Background This study aims to evaluate the effect of operative hysteroscopy and levonorgestrel-releasing intrauterine system (LNG-IUS) insertion for abnormal uterine bleeding on sexual function and, if it improves sexual function, to examine differences in sexual function between women undergoing hysteroscopy and women using LNG-IUS. Methods Ninety women aged between 25 and 52 enrolled in the study. Participants were divided into two groups, including 45 operative hysteroscopy patients and 45 LNG-IUS patients. All patients completed the Female Sexual Function Index (FSFI) questionnaire pre-treatment and after three months post-treatment. Pre- and post-treatment FSFI scores were compared both within and between groups. Results The mean FSFI scores at three months following both treatments were significantly higher than baseline in both groups (p<0.05). When the two groups were compared, no significant difference was observed between baseline and three-month post-treatment differences in FSFI scores except for the pain domain. In the pain domain of the FSFI questionnaire, a more significant improvement was found in the LNG - IUS inserted group compared to the operative hysteroscopy group. Conclusion Patients had improvement in sexual functions after both operative hysteroscopy and LNG - IUS insertion treatment. No significant difference was observed in hysteroscopy and LNG-IUS patients after both treatments in terms of sexual function according to scores calculated by FSFI, except for the pain domain. Significant improvement was observed in the pain domain of the FSFI for the LNG - IUS inserted group compared to the operative hysteroscopy group, thus demonstrating a significant effect and improvement for dyspareunia and chronic pelvic pain complaint in the LNG-IUS inserted group.

Evaluation of effects of levonorgestrel releasing intrauterine system in heavy menstrual bleeding

Heavy menstrual bleeding (HMB), is one of the most frequently encountered problem in the gynaecology OPD. It can significantly affect women’s quality of life and overburden health-care systems. The Levonorgestrel Releasing Intrauterine System (LNG-IUS) is a highly effective long-acting reversal contraceptive, also useful for controlling HMB and promoted by National Institute for Health and Care Excellence (NICE). This prospective interventional study conducted upon 30 women, with heavy menstrual bleeding, of 30-50 years’ age, reporting in the outpatient department of a tertiary health care facility unit “between” January 2018 to June 2019. Women, who met inclusion and exclusion criteria were our study population. Data was collected during follow up at 1, 3 and 6 month and all the association were tested by mean, proportion and percentages. Chi-square test was used for comparing categorical result and p-value of less than 0.05 was considered as statistically significant. Calculation was made by using IBM SPSS 26 version of statistical software. Majority of women were from 40-45 years’ age group. Pictorial Blood Loss Assessment Chart (PBAC) score was calculated in 30 women who underwent LNG IUS insertion.There was significant reduction (p&amp;#60;0.05) in the mean PBAC score at 3and 6month compared to their initial value after LNG-IUS insertion. LNG IUS is effective and can be used as first line measure for treatment of HMB.

Levonorgestrel-Releasing Intrauterine System Utilization in Patients with Developmental Delays

Adolescent females with developmental delays (DDs) experience unique physical and emotional challenges related to menstruation. Providers often recommend hormonal medication for menstrual management. The objective of our study was to describe the utilization and safety of the levonorgestrel-releasing intrauterine system (LNG-IUS) in adolescents with DDs. We utilized the Pediatric Health Information System to identify females aged 10-25 with DDs who underwent an LNG-IUS insertion between 2011 and 2020. Using a gynecologic procedure and diagnosis codes, we assessed indications for and complications of LNG-IUS use. We also evaluated early LNG-IUS removal. One thousand five hundred and sixty female patients with DDs underwent LNG-IUS insertion. LNG-IUS insertion under anesthesia was most commonly performed in patients with autism and Down syndrome, and unspecified menstrual issues were documented for 40% of the cohort. Perforation was observed in 11 patients (1%), and mechanical complications (malpositioned IUS or lost threads) were observed in 23 patients (1%). This is the largest analysis of LNG-IUS use in patients with DDs to our knowledge and shows the utilization of LNG-IUS in patients with DDs. We provide descriptive information that providers can use to accurately advise their patients with DDs on the risks and benefits of LNG-IUS use for menstrual management.

Real-world outcomes of the levonorgestrel-releasing intrauterine system for heavy menstrual bleeding or dysmenorrhea in Japanese patients: A prospective observational study (J-MIRAI)

ObjectivesWe collected real-world data on the safety and clinical outcomes of the levonorgestrel-releasing intrauterine system (LNG-IUS) for heavy menstrual bleeding and dysmenorrhea. Study DesignThis was a prospective, multicenter, single-cohort, open-label, post-authorization 12-month follow-up study of Japanese patients initiating the LNG-IUS for heavy menstrual bleeding and/or dysmenorrhea. The primary endpoint was the safety profile based on adverse events and adverse drug reactions (ADRs), including expulsions and abnormal bleeding, within 12 months of LNG-IUS insertion. Secondary endpoints included changes from baseline in menstrual blood loss based on bleeding days and dysmenorrhea graded on a visual analog scale (VAS). ResultsOf the 595 patients included, many had underlying conditions such as adenomyosis (39.5%), uterine leiomyoma (30.8%), or endometriosis (12.9%). The incidences of ADRs and serious ADRs were 59.7% and 0.3%, respectively. Frequently reported ADRs were metrorrhagia (48.9%), procedural pain (14.1%), and ovarian cyst (6.2%). The cumulative incidence of expulsions at 12 months was 8.7%. Risk factors for expulsion were obesity (body mass index ≥25 kg/m2), adenomyosis, and uterine cavity length ≥8 cm. The median [interquartile range] VAS score for dysmenorrhea improved from 46.5 [13.0–68.0] at insertion to 1.0 [0.0–13.0] at 12 months, and improvements were also observed in chronic pelvic pain and painful defecation. ConclusionsThe LNG-IUS safely and effectively reduced dysmenorrhea, chronic pelvic pain, and painful defecation. Risk factors for expulsion suggest that patients with underlying organic disease should be monitored carefully when using the LNG-IUS. ImplicationsThe LNG-IUS is an effective treatment for secondary dysmenorrhea with organic disease, and for the reduction of chronic pelvic pain; however, physicians should be aware of the increased risk of expulsion in patients with organic conditions.

Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting.

IntroductionThe present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (QOL) of Japanese women over the course of the investigational period.MethodsThis was a multicenter, non-interventional, prospective, single-cohort, post-marketing surveillance study (J-MIRAI). The primary outcome was the median change in the Menstrual Distress Questionnaire (MDQ) and Menorrhagia Multi-Attribute Scale (MMAS) scores from baseline to 3 and 12 months after LNG-IUS insertion, with decreasing and increasing scores, respectively, indicating improvement. The secondary outcomes were the statistical relationships between the MDQ and menstrual pain (measured by a visual analog scale, VAS), and between the MMAS and pictorial blood loss assessment chart (PBAC) scores by regression analysis.ResultsIn total, 593 patients were evaluated; 376, 467, and 250 patients were diagnosed with dysmenorrhea, HMB, or both, respectively. The median MDQ score decreased significantly at 3 and 12 months after LNG-IUS insertion in both the premenstrual and menstrual periods (both p < 0.001 vs baseline), and the median MMAS score showed a similar improvement during the menstrual period. Changes in median MDQ and MMAS scores were observed regardless of patient background. Correlations between MDQ and menstrual pain (VAS) and between MMAS and PBAC scores were found (estimated regression coefficients 0.29 and − 0.15, respectively).ConclusionThe LNG-IUS contributed to improvements in the QOL of patients with dysmenorrhea, HMB, and both, regardless of patient background characteristics.Trial RegistrationRegistered at ClinicalTrials.gov (NCT02475356) on 18 June 2015.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02205-2.

Bleeding patterns of women with heavy menstrual bleeding or dysmenorrhoea using the levonorgestrel-releasing intrauterine system: results from a real-world observational study in Japan (J-MIRAI)

Purpose To collect real-world safety and clinical outcome data on the levonorgestrel-releasing intrauterine system (LNG-IUS) for functional/organic heavy menstrual bleeding (HMB) and dysmenorrhoea in Japanese women (J-MIRAI). Materials and methods In this prospective, multicentre, single-cohort, open-label, post-authorisation study, we assessed menstrual blood loss after LNG-IUS insertion by changes from baseline in pictorial blood loss assessment chart (PBAC) scores. Scores for the menorrhagia multi-attribute scale (MMAS) were collected for 12 months to assess quality of life. Results We included 47 patients with complete PBAC score and patient diary data. The median PBAC score before LNG-IUS insertion was 159.0, which decreased significantly to 6.0 at 12 months post-insertion; for patients with adenomyosis (n = 20), PBAC score decreased from 174.5 pre-insertion to 19.5 at 12 months. The number of patient-reported bleeding days was correlated with PBAC score ≥5. The proportion of women with prolonged bleeding decreased from 85.7% to 34.6% by the study’s end. Some women reported no bleeding after the first 90-day reference period. The mean MMAS overall score significantly increased from 50.50 before insertion to 88.67 at 12 months. Conclusions Japanese women with functional/organic HMB experienced substantial reductions in bleeding symptoms and improvements in quality of life after 12-month use of the LNG-IUS.

Combined administration of Dienogest and Levonorgestrel – Releasing Intrauterine System Mirena

Objectives: Intrauterine hormone-releasing systems are now widely applied to treat metrorrhagia (polymenorrhea), endometrial hyperplasia and adenomyosis. In previous works we found that risk factors for expulsion of intrauterine device, besides the deformation of the uterine cavity, was the expansion of uterine cavity area &gt; 9 cm2, associated with increased distance between tubal angles &gt;4.5 cm and after the insertion of Levonorgestrel-releasing Intrauterine System (Mirena), among the patients with indicated parameters of uterine cavity, the expulsion reached 90%. Another widely used medicine for treatment of metrorrhagia (polymenorrhea), endometrial hyperplasia and adenomyosis is dienogest (Vizanna). The objective of this study is to explore the influence of combined administration of dienogest and Levonorgestrel- releasing Intrauterine System with the purpose of prevention of complications and side effects of the Intrauterine System. Study design: This prospective study includes 32 patients with previous Levonorgestrel-releasing Intrauterine System expultions whom Dienogest 2mg daily has been administered within 6 months. Results: Ultrasound transformation of a myometrium and uterine cavity in 6 months after Vizanna administration was manifested by minimization of uterine cavity and reduction of distance between tubal angles. Mirena was inserted to these patients again. Within 12 months of monitoring any case of expulsion was not observed. Conclusions: According to the data received, the combined consistent and simultaneous administration of Dienogest and Mirena reduces the possibility of Intrauterine System expulsion and decreases side effects of the Intrauterine System. Implication statement: Combined consistent and simultaneous administration of Dienogest and Levonorgestrel-releasing Intrauterine System was used for prevention of complications of Intrauterine System

Use of naproxen versus intracervical block for pain control during the 52-mg levonorgestrel-releasing intrauterine system insertion in young women: a multivariate analysis of a randomized controlled trial

BackgroundTo compare the effectiveness of 550 mg naproxen sodium versus 6 mL 2%-lidocaine intracervical block in pain lowering at the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) placement in young women.MethodsIn this randomized controlled trial, 100 women aged 15–24 years were block-randomized to receive either 6 mL 2%-lidocaine intracervical block 5 min before the LNG-IUS insertion or 550 mg naproxen 30 min before the procedure. Forty-nine women received 550 mg naproxen and 51 received intracervical block. The primary outcome was pain at LNG-IUS insertion. Secondary outcomes were ease of insertion, insertion failures, and correct IUS positioning. Neither participants nor doctors were blinded. Pain at insertion was assessed by using a Visual Analog Scale (VAS).ResultsWomen randomized to lidocaine intracervical block presented lower mean pain score at insertion, when compared to women who received naproxen (5.4 vs. 7.3, respectively; p < 0.001). Parous women had a 90.1% lower chance of experiencing severe pain (p = 0.004). There was a 49.8% reduction in the chance of severe pain for every 1-cm increase in the hysterometry (p = 0.002). The only complication observed during insertion was vasovagal-like reactions (7%). The insertion was performed without difficulty in 82% of the women. Participants in the intracervical block group presented higher proportion of malpositioned IUS on transvaginal ultrasound examination compared to women in naproxen group. Nevertheless, all the malpositioned IUS were inserted by resident physicians.ConclusionLidocaine intracervical block was found to be more effective than naproxen in reducing LNG-IUS insertion pain.Trial registration number: RBR-68mmbp, Brazilian Registry of Clinical Trials, Retrospectively registered (August 4, 2020), URL of trial registry record: https://ensaiosclinicos.gov.br/rg/RBR-68mmbp/.

Pain scores at the insertion of the 52 MG levonorgestrel-releasing intrauterine system among nulligravidas and parous women

Purpose This study aimed to assess the pain scores at the insertion of the 52 mg levonorgestrel-releasing intrauterine system (LNG-IUS) among nulligravidas, parous women with previous vaginal delivery and parous women with elective caesarean-delivery without any previous labour or cervix dilation. Materials and methods The present research is a prospective, single-cohort study that included 413 women aged 15–49 years who opted for LNG-IUS placement for contraception or treatment of heavy menstrual bleeding. Women who participated in the present study were not submitted to any pharmacological pain-relieving intervention to perform the procedure. Pain at insertion was evaluated by using a Visual Analogue Scale (VAS). Pain was classified as absent (0), mild (1–3), moderate (4–6), or severe (7–10). The women were divided as: (1) nulligravidas, (2) parous women with a previous vaginal delivery, or (3) parous women with elective caesarean-delivery without any previous labour or cervix dilation. Results Nulligravidas women presented a higher mean pain score, when compared to women with elective caesarean-delivery and women with previous vaginal delivery (6.6 ± 2.0 vs 5.5 ± 2.1 and 3.9 ± 2.4, respectively; p < 0.001). Nulligravidas and women with elective caesarean-delivery were more likely to have pain classified as moderate or severe (in relation to absent or mild) than women with previous vaginal delivery (p < 0.001). Multiple Linear Regression Analysis demonstrated that 29.5% of all variability of the pain score was explained by two predictor/independent variables: nulligravidas or women with elective caesarean and difficulty at IUD insertion. Conclusions Women with previous vaginal delivery had lower pain scores at LNG-IUS insertion when compared to nulligravidas and women with elective caesarean-delivery without any previous labour.

The treatment with Levonorgestrel Releasing Intrauterine System (LNG-IUS) in patients affected by menometrorrhagia, dysmenorrhea and adenomimyois: clinical and ultrasonographic reports.

Adenomyosis is the consequence of the myometrial invasion by endometrial glands and stroma. Transvaginal ultrasonography plays a decisive role in the diagnosis and monitoring of this pathology. Our study aims to evaluate the efficacy of LNG-IUS (Levonorgestrel Releasing Intrauterine System) as medical therapy. We analyzed both clinical symptoms and ultrasonographic aspects of menometrorrhagia and dysmenorrhea in patients with adenomyosis and the control group. A prospective cohort study was carried out on 28 patients suffering from symptomatic adenomyosis treated with LNG-IUS. Adenomyosis was diagnosed through transvaginal ultrasonography by an expert sonographer. A control group of 27 symptomatic patients (menorrhagia and dysmenorrhea) without a transvaginal ultrasonographic diagnosis of adenomyosis was treated in the same way. The two cohorts were compared to the efficacy of LNG-IUS on menorrhagia and dysmenorrhea. Patients are evaluated at the time of LNG-IUS insertion and six months after for: increased uterine volume, globulous uterine morphology, uterine symmetry, alterations in the junctional zone, heterogeneous myometrial texture, presence of myometrial cysts, hyperechogenic lines crossing the myometrium, adenomyomas, menstrual blood loss and dysmenorrhea. After six months, the uterine volume decreased significantly in both cohorts (p=0.005; p=0.005). Furthermore, uterine symmetry, visibility of the junctional zone, heterogeneity of myometrial texture, presence of myometrial cysts, hyperechogenic lines and adenomyomas improved in patients affected by adenomyosis (p>0.001; p>0.001; p>0.001; p=0.014; p=0.025; p=0.014). The blood loss decreased significantly in both the cohorts (p<0.001) and particularly in adenomyotic patients. Pain relief was observed in all the patients (p<0.001). LNG-IUS can be considered an effective treatment for managing symptoms and improving uterine morphology.

Intracervical block decreases severe pain during insertion of levonorgestrel-releasing intrauterine system in nulliparous women

Intracervical block decreases severe pain during insertion of levonorgestrel-releasing intrauterine system in nulliparous women

Levonorgestrel-Releasing Intrauterine System Use in Perimenopausal Women.

The levonorgestrel-releasing intrauterine system (LNG-IUS) is a highly effective contraceptive method that has several noncontraceptive benefits. It has been used in various gynecological conditions, such as heavy menstrual bleeding, dysmenorrhea, and endometrial hyperplasia. During the perimenopausal period, hormonal fluctuations occur, and there is a high tendency for the development of several benign gynecologic diseases. Therefore, the use of LNG-IUS in perimenopausal women might be more beneficial than in women belonging to other age groups. Moreover, the insertion of LNG-IUS during the perimenopausal period could confer endometrial protection during estrogen replacement therapy. In this review, we discuss the use of LNG-IUS in perimenopausal women.

The effect of a levonorgestrel-releasing intrauterine device on female sexual function

This study aimed to evaluate the effect of a levonorgestrel-releasing intrauterine system (LNG-IUS) on the sexual function of women. Participants who had abnormal uterine bleeding (AUB) complaints with LNG-IUSs were included (study registration: Kanuni Sultan Suleyman Training and Research Hospital, 2018/10/34). The demographic data of all participants were recorded. The female sexual function index (FSFI) questionnaire was used to participants before the insertion of LNG-IUSs and 6 months after its insertion. FSFI scores were calculated at both timepoints and were compared. The total FSFI score after LNG-IUS insertion was significantly higher than the total FSFI score application (p < .001). The scores of the desire, arousal, lubrication, orgasm, satisfaction and pain categories significantly increased after LNG-IUS compared to those before LNG-IUS. As a result, the present study demonstrated that after LNG-IUS insertion, these women had higher FSFI scores. Impact Statement What is already known on this subject? There are many publications in the literature comparing the effects of LNG-IUSs, IUSs, OCs and other contraceptive methods on female sexuality. However, there are markedly few studies that compare sexual function before and after LNG-IUS insertion. What do the results of this study add? The total FSFI score after LNG-IUS insertion was significantly higher than the total FSFI score before the insertion (p < .001). The scores of the desire, arousal, lubrication, orgasm, satisfaction and pain categories significantly increased after LNG-IUS insertion compared to those before the application. The number of participants with FSFI scores ≥26.5 before LNG-IUS insertion was 17 (12.5%), and this number increased to 71 (52.5%) after the application What are the implications of these findings for clinical practice and/or further research? This study contributes to the literature because there are few researches that compare sexual function before and after LNG-IUS insertion. As a result of our study, sexual dysfunction decreased after LNG-IUS, and the scores increased in all sub-groups together with the total FSFI scores.

Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial.

This study aimed at investigating the efficacy and safety of dinoprostone 3mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD). We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects. Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3; p < 0.001). Dinoprostone reduced pain scores 30min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1; p < 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups. Dinoprostone administration 2h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.

Analysis of the effect and safety of levonorgestrel-releasing intrauterine system on patients with breast cancer who take tamoxifen

Objective To analyze the effect and safety of levonorgestrel-releasing intrauterine system(LNG-IUS) for the premenopausal patients with breast cancer who took tamoxifen as adjuvant therapy. Methods From June 2014 to June 2016, 84 patients with breast cancer who met the inclusion criteria in the First People′s Hospital of Xiaoshan District were randomly divided into two groups according to the digital table.The treatment group (39 cases) underwent LNG-IUS insertion, while the control group (45 cases) received no LNG-IUS insertion.The general condition of patients before the use of tamoxifen and LNG-IUS was evaluated.Transvaginal ultrasound was used to measure the thickness of endometrium, hysteroscope was used for pathological examination of endometrium and the measurement of ER/PR expression, and blood lipid level was also detected.All above was done before the treatment of tamoxifen and LNG-IUS, 1 year after treatment and 2 years after treatment. Results Before the therapy, there were no statistically significant differences between the two groups in general condition and uterine cavity condition(all P>0.05). After 1 year, the incidences of endometrial polyp, endometrial hyperplasia/secretion, benign lesion and endometrial atrophy in the treatment group were 2.6%, 5.1%, 15.4%, 76.9%, respectively, which in the control group were 6.7%, 20.0%, 17.8%, 55.6%, respectively.the differences between the two groups were statistically significant(χ2=4.06, 4.22, all P<0.05). After 2 years, the incidences of endometrial polyp, endometrial hyperplasia/secretion, benign lesion and endometrial atrophy in the treatment group were 0.0%, 2.6%, 84.6%, respectively, which in the control group were 11.1%, 15.6%, 60.0%, respectively, the differences between the two groups were statistically significant(χ2=4.608, 4.092, 6.203, all P<0.05). Conclusion LNG-IUS can prevent the benign endometrial lesions of breast cancer patients caused by tamoxifen therapy after surgery, and can decrease the incidence of endometrial polyp and endometrial hyperplasia/secretion, while increase the incidence of endometrial atrophy, without increasing the recurrence risk of breast cancer. Key words: Intrauterine devices, Medicated; Levonorgestrel; Tamoxifen; Breast neoplasms; Premenopause; Endometrium

The influence of the levonorgestrel‐releasing intrauterine system position on bleeding patterns in reproductive age women

To determine whether users of the non-fundal levonorgestrel-releasing intrauterine system (LNG-IUS) present with unfavorable bleeding patterns more frequently than fundal LNG-IUS users. A prospective cohort was conducted from June, 2016 to January, 2018 involving women aged 18-45years who wished to use the LNG-IUS as contraception and had no contraindications, endometrial polyps, submucosal myomas, irregular menstrual cycle, or anticoagulant use. Two study groups comprised women using fundal insertion and non-fundal insertion LNG-IUS. Bleeding was evaluated using a diary and pictogram chart. Of the 92 women who participated in the study, those with non-fundal LNG-IUS insertion sustained bleeding at rates greater than 83% (31) in the first 3months of use, and 58% (14) at 6months, versus 51% (22) at 3months and 33% (19) at 6months in those with fundal insertion (P=0.002 at 3months; P=0.037 at 6months). Blood loss in the non-fundal LNG-IUS group was higher than in the fundal LNG-IUS group according to pictograms drawn by participants. Women with non-fundal LNG-IUS placement had a higher frequency of sustained bleeding and blood loss volume according to self-reported charts than those with fundal LNG-IUS placement.

Intracervical block for levonorgestrel-releasing intrauterine system placement among nulligravid women: a randomized double-blind controlled trial

Fear of pain during the insertion of intrauterine contraceptives is a barrier to using these methods, especially for nulligravidas. An intracervical block may be easier and more reproducible than a paracervical block; however, this intervention has not been evaluated in nulligravid women to reduce pain with intrauterine contraceptive insertion. To evaluate whether a 3.6-mL 2% lidocaine intracervical block reduces pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas; and, in addition, to assess whether the intracervical block has any effect on the ease of device insertion and on the overall experience with the procedure. In this randomized double-blind controlled trial, nulligravidas were block-randomized to 1 of 3 arms prior to 52-mg levonorgestrel-releasing intrauterine system insertion: 3.6-mL 2%-lidocaine intracervical block, sham injection (intracervical dry-needling), or no intervention. The primary outcome was pain at levonorgestrel-releasing intrauterine system insertion. Secondary outcomes were pain at tenaculum placement, ease of insertion (assessed by healthcare providers), and the overall experience with the procedure (pain with levonorgestrel-releasing intrauterine system insertion compared with expectations, discomfort level, wish to undergo another device insertion in the future, and recommendation of the procedure to others). Participants' pain was measured with a 10-cm visual analogue scale and a 5-point Faces Pain Scale. Pain was summarized into categories (none, mild, moderate, severe) and also analyzed as a continuous variable (mean and 95% confidence interval). Our sample size had 80% power (α= 0.05) to detect a 15% difference in pain score measured by visual analogue scale (mean [standard deviation] visual analogue scale score= 5.9 [2.0] cm) and an absolute difference of 20% in the proportion of women reporting severe pain at levonorgestrel-releasing intrauterine system insertion among groups. We used a χ2 test and a mixed-effects linear regression model. We calculated the number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion. A total of 302 women were randomized (99 to the intracervical block, 101 to the intracervical sham, and 102 to no intervention), and 300 had a successful device insertion. The intracervical block group had fewer women reporting severe pain than the other groups, both at tenaculum placement (intracervical block: 2% vs sham: 30.2% vs no intervention: 15.2%, P < .0001) and at levonorgestrel-releasing intrauterine system insertion (intracervical block: 26.5% vs sham: 59.4% vs no intervention: 50.5%, P < .0001). The mean (95% confidence interval) pain score reported at levonorgestrel-releasing intrauterine system insertion was lower in the intracervical block group than in the other groups (intracervical block: 4.3 [3.8-4.9] vs sham: 6.6 [6.2-7.0], P < .0001; intracervical block: 4.3 [3.8-4.9] vs no intervention: 5.8 [5.3-6.4], P < .0001). Women from the intracervical block group reported less pain than expected (P < .0001), rated the insertion as less uncomfortable (P < .0001), and were more willing to undergo another device insertion in the future (P < .01) than women in the other groups. The ease of insertion were similar among groups. The number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion was 2 and 4, respectively. A 3.6-mL 2% lidocaine intracervical block decreased pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas. It also provided a better overall experience during the procedure.