Ovarian stimulation protocols: impact on oocyte and endometrial quality and function.

Ovarian stimulation (OS) truly is an art. There exists a myriad of protocols used to achieve the same goal: stimulating the ovaries to produce more than one mature oocyte to improve the chance of a live birth. However, considerable debate remains as to whether OS impacts oocyte and endometrial quality to affect in vitro fertilization outcomes.

GnRH agonists in the treatment of symptomatic endometriosis: a review.

The development of highly potent gonadotropin-releasing hormone agonists (GnRHa) allowed for a significant addition to options for the medical management of symptomatic endometriosis. Pituitary GnRH receptor down-regulation leads to a hypogonadotropic and secondary hypoestrogenic state resulting in lesion regression and symptom improvement. There may be an additional effect of these agents on the inflammatory processes associated with endometriosis as well.

Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients.

Background: Elagolix is an oral, gonadotropin-releasing hormone (GnRH) receptor antagonist, that significantly reduces dysmenorrhea and non-menstrual pelvic pain (NMPP) in women with moderate to severe endometriosis-associated pain.

Methods: Data were pooled from two 6-month, placebo-controlled, phase 3 studies (Elaris Endometriosis [EM]-I and II) in which 2 doses of elagolix were evaluated (150 mg once daily and 200 mg twice daily). Pooled data from > 1600 women, aged 18-49, were used to evaluate the efficacy of elagolix and health-related quality of life (HRQoL) in prespecified subgroups of women with various baseline characteristics.

Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix.

Objective: In this post hoc analysis, we evaluated the impact of elagolix on dysmenorrhea and nonmenstrual pelvic pain across menstrual period (bleeding days) and nonmenstrual (nonbleeding) days.

Methods: Data from two randomized, 6-month, placebo-controlled trials (Elaris Endometriosis (EM)-I and EM-II) of elagolix (150 mg once daily (QD) and 200 mg twice daily (BID)) in premenopausal women with moderate to severe endometriosis-associated pain (N = 1686) were pooled. Women recorded the presence of menstrual period and severity of dysmenorrhea or nonmenstrual pelvic pain in a daily electronic diary.

Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.

Background: Endometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often included as an endpoint in clinical trials.

Objectives: The study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.

Real-World Characterization of Women with Diagnosed Endometriosis Initiating Therapy with Elagolix Using a US Claims Database.

Purpose: Elagolix is an oral gonadotropin-releasing hormone antagonist approved in the United States for the management of moderate to severe pain associated with endometriosis. We performed a real-world evaluation of the demographic and clinical characteristics of women diagnosed with endometriosis who were initiating elagolix therapy in the United States.

Patients And Methods: This retrospective cohort database analysis included women 18-49 years of age with ≥1 pharmacy claim for elagolix between August 2018 and December 2019 from the Copyright © 2020 Truven Health Analytics LLC.

Patients' perspectives of endometriosis-related fatigue: qualitative interviews.

Background: Endometriosis-related fatigue is common and negatively impacts multiple areas of many women's lives, particularly in day-to-day activities, social activities, physical activities, mood and emotions, relationships with family or partners, and work or school. Multiple studies have documented fatigue as a significant symptom of endometriosis. Additional research is needed to better understand endometriosis-related fatigue and its impacts on patients.

Impact of Endometriosis Diagnostic Delays on Healthcare Resource Utilization and Costs.

Introduction: Endometriosis symptoms are nonspecific and overlap with other gynecologic and gastrointestinal diseases, leading to long diagnostic delays. The burden of endometriosis has been documented; however, little is known about the impact of diagnostic delays on healthcare costs leading up to diagnoses. The purpose of this study was to examine the economic impact of diagnostic delays on pre-diagnosis healthcare utilization and costs among patients with endometriosis.

Achieving clinically meaningful response in endometriosis pain symptoms is associated with improvements in health-related quality of life and work productivity: analysis of 2 phase III clinical trials.

Background: Endometriosis-related pain symptoms have a negative impact on health-related quality of life and productivity. In fact, as endometriosis-related symptom severity and the number of symptoms experienced increases, health-related quality of life decreases. Dysmenorrhea and nonmenstrual pelvic pain are prominent symptoms experienced by women with endometriosis and were shown to have improved with the oral, nonpeptide gonadotropin-releasing hormone antagonist, elagolix.

Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials.

Background: Endometriosis profoundly impairs women's workplace and household productivity.

Objective: The aim of this study was to evaluate the impact of elagolix on endometriosis-related workplace and household productivity losses.

Methods: Data were pooled from two phase III trials of women aged 18-49 years with moderate to severe endometriosis-associated pain treated for 6 months with elagolix 150 mg daily (QD), 200 mg twice daily (BID), or placebo.

Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials.

Objective: To estimate the impact of elagolix on work loss due to endometriosis-associated pain.

Design: Post hoc analysis of data from the Elaris I and II clinical trials.

Setting: Not applicable.

Health Care Utilization and Costs Associated with Endometriosis Among Women with Medicaid Insurance.

Background: Endometriosis is a painful chronic inflammatory disease caused by endometrial tissue implanting and growing outside the uterus, resulting in pelvic pain symptoms and subfertility. Treatment imposes a substantial economic burden on the patient and health care system.

Objective: To evaluate direct health care utilization and costs among women newly diagnosed with endometriosis compared with age-matched controls in a U.

Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis.

Objective: To evaluate the efficacy of elagolix, an oral GnRH antagonist, for the reduction of fatigue in women with moderate or severe endometriosis-associated pain.

Design: Randomized, double-blind, multicenter, placebo-controlled phase III trial.

Setting: Clinics.

A multicentre evaluation of the Elecsys anti-Müllerian hormone immunoassay for prediction of antral follicle count.

Research Question: What concentration of anti-Müllerian hormone (AMH) corresponds to an antral follicle count (AFC) >15 for determination of ovarian reserve?

Design: A prospective study conducted at 13 US fertility clinics in women aged 21-44 years who presented for AFC evaluation by transvaginal ultrasound. Serum samples were collected at the time of AFC evaluation (menstrual cycle day 2-4). AMH concentrations were measured by the Elecsys AMH immunoassay; oestradiol and follicle-stimulating hormone (FSH) concentrations were also measured.

Development of the Painful Periods Screening Tool for endometriosis.

Objectives: Diagnostic delay is common in endometriosis. There is an unmet need for a symptom-based, patient-completed screening tool to facilitate discussions between patients and physicians about potential endometriosis symptoms. The objective of this study was to develop and assess the patient-completed Painful Periods Screening Tool (PPST) to assess the presence of potential endometriosis symptoms.

Reintervention Rates After Myomectomy, Endometrial Ablation, and Uterine Artery Embolization for Patients with Uterine Fibroids.

Background: Women with uterine fibroids (UF) may undergo less invasive procedures than hysterectomy, including myomectomy, endometrial ablation (EA), and uterine artery embolization (UAE); however, long-term need for reintervention is not well characterized. We estimated reintervention rates for 5 years and identified predictors of reintervention.

Materials And Methods: A longitudinal retrospective cohort study was conducted in women in MarketScan Commercial Claims and Encounters (Truven Health Analytics) aged 18-49 years with UF diagnosis before myomectomy, EA, or UAE from 2008 to 2014.

Risk of Developing Comorbidities Among Women with Endometriosis: A Retrospective Matched Cohort Study.

Background: Endometriosis has been associated with higher rates of various chronic conditions, but its epidemiological data are fragmented and dated. We sought to compare the incidence of developing commonly occurring comorbidities among patients with and without endometriosis in a large, contemporary patient cohort that reflects real-world clinical practice.

Materials And Methods: A cohort of women aged 18-49 with incident endometriosis was extracted from the 2006-2015 de-identified Clinformatics DataMart commercial insurance claims database (OptumInsight, Eden Prairie, MN).

Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies.

Objective: To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain.

Methods: Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores.

An evidence-based approach to assessing surgical versus clinical diagnosis of symptomatic endometriosis.

Challenges intrinsic to the accurate diagnosis of endometriosis contribute to an extended delay between the onset of symptoms and clinical confirmation. Intraoperative visualization, preferably with histologic verification, is considered by many professional organizations to be the gold standard by which endometriosis is diagnosed. Clinical diagnosis of symptomatic endometriosis via patient history, physical examination, and noninvasive tests, though more easily executed, is generally viewed as less accurate than surgical diagnosis.

Arcuate uterus: is there an impact on in vitro fertilization outcomes after euploid embryo transfer?

Objective: To study the impact of the arcuate uterus on euploid blastocyst-stage embryo transfer outcomes after comprehensive chromosomal screening (CCS).

Design: Controlled retrospective trial.

Setting: Tertiary care assisted reproduction technology (ART) center.

Real-World Evaluation of Direct and Indirect Economic Burden Among Endometriosis Patients in the United States.

Introduction: The prevalence of endometriosis and the need for treatment in the USA has led to the need to explore the contemporary cost burden associated with the disease. This retrospective cohort study compared direct and indirect healthcare costs in patients with endometriosis to a control group without endometriosis.

Methods: Women aged 18-49 years with endometriosis (date of initial diagnosis = index date) were identified in the Truven Health MarketScan Commercial database between 2010 and 2014 and female control patients without endometriosis were matched by age and index year.

Changes in Healthcare Spending After Diagnosis of Comorbidities Among Endometriosis Patients: A Difference-in-Differences Analysis.

Introduction: We sought to characterize changes in healthcare spending associated with the onset of 22 endometriosis-related comorbidities.

Methods: Women aged 18-49 years with endometriosis (N = 180,278) were extracted from 2006-2015 de-identified Clinformatics DataMart claims data. For 22 comorbidities, comorbidity patients were identified on the basis of having a first comorbidity diagnosis after their initial endometriosis diagnosis.