Dataset Information

Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Obese women have fewer oocytes retrieved, an increased cancelation rate, a higher miscarriage rate, and a lower live birth rate after assisted reproductive technology (ART) treatment compared with women with normal weight. Weight loss before ART treatment can significantly improve pregnancy rates and/or live births. An orlistat plus diet intervention could promote weight loss, but there is no evidence from randomized clinical trials evaluating the effect of orlistat preconceptional treatment on pregnancy outcome in overweight and obese women.

Methods/design

We are conducting a multicenter, randomized placebo-controlled, double-blind clinical trial in overweight and obese women aged 20-40 years undergoing in-vitro fertilization and embryo transfer (IVF-ET) with or without intracytoplasmic sperm injection, to evaluate whether orlistat treatment for 1-3 months before IVF-ET can improve the live birth rate. The primary outcome is live birth.

Discussion

The results of this study will provide evidence for the effect of preconceptional orlistat treatment on IVF outcome in overweight/obese women.

Trial registration

Chinese Clinical Trial Registry, ChiCTR-IPR-17011629 . Registered on 11 June 2017.

SUBMITTER: Li J

PROVIDER: S-EPMC6052605 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial.

Li Jing J Wang Ze Z Wei Daimin D Liu Hong H Zhang Jiangtao J Wang Jianfeng J Shi Yuhua Y Chen Zi-Jiang ZJ

Trials 20180718 1

<h4>Background</h4>Obese women have fewer oocytes retrieved, an increased cancelation rate, a higher miscarriage rate, and a lower live birth rate after assisted reproductive technology (ART) treatment compared with women with normal weight. Weight loss before ART treatment can significantly improve pregnancy rates and/or live births. An orlistat plus diet intervention could promote weight loss, but there is no evidence from randomized clinical trials evaluating the effect of orlistat preconcept ...[more]

PMID: 30021634

Similar Datasets

Project description:The proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.Overweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period.Hispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.NCT01868230 May 29, 2013.

Project description:BackgroundOverweight and obesity among young, adult women are increasing problems in Sweden as in many other countries. The postpartum period may be a good opportunity to improve eating habits and lose weight in a sustainable manner. The aim was to make a cost-utility analysis of a dietary behavior modification treatment alongside usual care, compared to usual care alone, among lactating overweight and obese women.MethodsThis study was a cost-utility analysis based on a randomized controlled and longitudinal clinical diet intervention. Between 2007-2010, 68 women living in Sweden were, after baseline measurement at 8-12 weeks postpartum, randomly assigned to a 12-week dietary behavior modification treatment or control group. Inclusion criteria were: self-reported pre-pregnancy body mass index (BMI) 25-35 kg/m2, non-smoker, singleton term delivery, birth weight > 2500 g, intention to breastfeed for 6 mo and no diseases (mother and child). The women in the intervention group received 1.5 hour of individual counseling at study start and 1 hour at follow-up home visits after 6 weeks of intervention, with support through cell phone text messages every two wk. Dietary intervention aimed to reduce dietary intake by 500 kcal/day. The control group received usual care. Weight results have previously been reported. Here we report on analyses carried out during 2012-2013 of cost per quality adjusted life years (QALY), based on the changes in quality of life measured by EQ-5D-3 L and SF-6D. Likelihood of cost-effectiveness was calculated using Net Monetary Benefit method.ResultsBased on conservative assumptions of no remaining effect after 1 year follow-up, the diet intervention was cost-effective. Costs per gained QALY were 8 643 - 9 758 USD. The likelihood for cost-effectiveness, considering a willingness to pay 50 000 USD for a QALY, was 87-93%.ConclusionsThe diet intervention is cost-effective.Trial registrationClinicalTrials.gov Identifier: NCT01343238 Registered April 27, 2011.The regional ethics committee in Gothenburg, Sweden, approved the study on November 15, 2006.

Project description:BackgroundGestational Diabetes Mellitus (GDM) has well recognised adverse health implications for the mother and her newborn that are both short and long term. Obesity is a significant risk factor for developing GDM and the prevalence of obesity is increasing globally. It is a matter of public health importance that clinicians have evidence based strategies to inform practice and currently there is insufficient evidence regarding the impact of dietary and lifestyle interventions on improving maternal and newborn outcomes. The primary aim of this study is to measure the impact of a telephone based intervention that promotes positive lifestyle modifications on the incidence of GDM. Secondary aims include: the impact on gestational weight gain; large for gestational age babies; differences in blood glucose levels taken at the Oral Glucose Tolerance Test (OGTT) and selected factors relating to self-efficacy and psychological wellbeing.Method/designA randomised controlled trial (RCT) will be conducted involving pregnant women who are overweight (BMI >25 to 29.9 k/gm2) or obese (BMI >30?kgm/2), less than 14 weeks gestation and recruited from the Barwon South West region of Victoria, Australia. From recruitment until birth, women in the intervention group will receive a program informed by the Theory of Self-efficacy and employing Motivational Interviewing. Brief ( less than 5 minute) phone contact will alternate with a text message/email and will involve goal setting, behaviour change reinforcement with weekly weighing and charting, and the provision of health information. Those in the control group will receive usual care. Data for primary and secondary outcomes will be collected from medical record review and a questionnaire at 36 weeks gestation.DiscussionEvidence based strategies that reduce the incidence of GDM are a priority for contemporary maternity care. Changing health behaviours is a complex undertaking and trialling a composite intervention that can be adopted in various primary health settings is required so women can be accessed as early in pregnancy as possible. Using a sound theoretical base to inform such an intervention will add depth to our understanding of this approach and to the interpretation of results, contributing to the evidence base for practice and policy.Trial registrationThis trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000125729.

Dataset Information

Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets