Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

Acknowledgments: We thank all the women who participated in this trial; the participating general practitioners, gynecologists, and hospitals; the research nurses; and the staff of the Dutch Consortium for Studies in Women’s Health and Reproduction.Peer reviewedPublisher PD

A case study of the applicability of a prediction model for the selection of patients undergoing in vitro fertilization for single embryo transfer in another center

Objective: To evaluate the application in a different fertility clinic of a prediction model for selecting IVF patientsfor elective single embryo transfer.Design: Retrospective analysis of a large database obtained from a tertiary infertility center.Setting: University medical center.Patient(s): The model, derived at the “development center” was applied in 494 consecutive first IVF cyclescarried out at the “application center.”Intervention(s): After adjustment of embryo scoring system to be compatible with that used by the predictionmodel, it was applied to the development center data. A score chart for predicting the probability of singleton ortwin pregnancy was constructed.Main Outcome Measure(s): The area under the receiver operator curve (ROC) was determined to measure theability of the model to discriminate between ongoing pregnancy and twin pregnancy. Calibration plots were madeto assess agreement between predicted and observed pregnancy rates (PR).Results: The areas under the ROC for predicting ongoing pregnancy and twin pregnancy were 0.63 and 0.66,respectively. Insertion of a correction factor equivalent to the difference in odds ratios for ongoing PR betweenthe two centers was required to improve the calibration of the model.Conclusion(s): After adaptation, the model performed well in the application center

A mild treatment strategy for in-vitro fertilisation: a randomised non-inferiority trial

Over 1 year of treatment, cumulative rates of term livebirths and patients' discomfort are much the same for mild ovarian stimulation with single embryos transferred and for standard stimulation with two embryos transferred. However, a mild IVF treatment protocol can substantially reduce multiple pregnancy rates and overall costs

MisoREST: Surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: A cohort study

Objective: To assess the effectiveness of curettage versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. Study design: We conducted a multicenter cohort study alongside a randomized clinical trial (RCT) between June 2012 until July 2014. 27 Dutch hospitals participated. Women with an incomplete evacuation after misoprostol treatment for first trimester miscarriage who declined to participate in the RCT, received treatment of their preference; curettage (n = 65) or expectant management (n = 132). A successful outcome was defined as an empty uterus on sonography at six weeks or uneventful clinical follow-up. We furthermore assessed complication rate and (re)intervention rate Results: Of the 197 women who declined to participate in the RCT, 65 preferred curettage and 132 expectant management. A successful outcome was observed in 62/65 women (95%) in the surgical group versus 112/132 women (85%) in the expectant group (RR 1.1, 95% CI 1.03-1.2), with complication rates of 6.2% versus 2.3%, respectively (RR 2.7, 95% CI 0.6-12). Conclusion: In women with an incomplete evacuation of the uterus after misoprostol treatment, expectant management is an effective and safe option. This finding could restrain the use of curettage in women that have used misoprostol in the treatment of first trimester miscarriage. (C) 2017 Elsevier B.V. All rights reserved

MisoREST : Surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: A cohort study

OBJECTIVE: To assess the effectiveness of curettage versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. STUDY DESIGN: We conducted a multicenter cohort study alongside a randomized clinical trial (RCT) between June 2012 until July 2014. 27 Dutch hospitals participated. Women with an incomplete evacuation after misoprostol treatment for first trimester miscarriage who declined to participate in the RCT, received treatment of their preference; curettage (n=65) or expectant management (n=132). A successful outcome was defined as an empty uterus on sonography at six weeks or uneventful clinical follow-up. We furthermore assessed complication rate and (re)intervention rate RESULTS: Of the 197 women who declined to participate in the RCT, 65 preferred curettage and 132 expectant management. A successful outcome was observed in 62/65 women (95%) in the surgical group versus 112/132 women (85%) in the expectant group (RR 1.1, 95% CI 1.03-1.2), with complication rates of 6.2% versus 2.3%, respectively (RR 2.7, 95% CI 0.6-12). CONCLUSION: In women with an incomplete evacuation of the uterus after misoprostol treatment, expectant management is an effective and safe option. This finding could restrain the use of curettage in women that have used misoprostol in the treatment of first trimester miscarriage

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage:the MisoREST trial

<p>Background: Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol.</p><p>Methods/Design: The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization. Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity <10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry.</p><p>Discussion: This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.</p>

Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding:a multicentre randomised controlled trial

<p>Background: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities.</p><p>Method/design: A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate.</p><p>Women >= 34 years with heavy menstrual bleeding, a Pictorial Blood Assessment Chart (PBAC) score exceeding 150 points and no future child wish can participate in the trial. After informed consent, women will be randomised to a strategy starting with a levonorgestrel releasing intrauterine system or a strategy starting with endometrial ablation.</p><p>The primary outcome is the PBAC score at 24 months of follow-up. Secondary outcomes are patient satisfaction, complications, number of re-interventions, menstrual bleeding pattern, quality of life, sexual function, sick leave and costs. As predictors of effect of intervention we also meaure level of coagulation factors.</p><p>Discusson: This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding.</p>