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临床试验/NCT03426228
NCT03426228已完成不适用

Effects of Fertility Drugs on Glucose Homeostasis and Other Metabolic Parameters on Patients Undergoing In Vitro Fertilization (IVF)

University of Warwick1 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2018年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
344
试验地点
1
主要终点
Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment

研究概览

简要总结

A quantitative prospective cohort study will be conducted, where blood samples will be collected at different timings during the IVF protocol, to assess the impact of fertility medications on metabolic parameters of patients undergoing IVF treatment.

详细描述

Numerous factors predispose women to develop pregnancy-related complications, these include gestational diabetes (GDM), pre-pregnancy obesity, advanced maternal age (> 35 years) and gestational age, abnormal weight gain during pregnancy, family history of diabetes, PCOS and low parity. Evidenced-based studies reported that women with PCOS have a significantly higher risk of developing GDM compared with women without PCOS, independently of the obesity factor; this risk is higher when both factors coexist.

Given the known effect of reproductive hormones on weight-gain, controversies still exist on whether ART predispose women to more adverse obstetric outcomes compared to normal pregnancy. ART describes different procedures to help women become pregnant, with In Vitro Fertilization (IVF) being the most commonly performed. It has been demonstrated that IVF is associated with glucose intolerance in mice and it will be interesting to determine whether this physiologic phenomenon is also altered by IVF medication (such as estrogen and progesterone) in humans. While some studies reported that singleton pregnancies conceived by ART (IVF or ovulation induction) were strongly associated with GDM compared to spontaneous conceptions, other studies did not find significant differences in the risk of GDM. Increased GDM risk presented with IVF can be associated with prenatal obesity or secondary to maternal PCOS condition. The former studies did not specify the body mass index (BMI) and the medical history of participants undergoing IVF, such as the presence of PCOS. Due to limited available data, we still cannot distinguish whether these adverse pregnancy outcomes are due to the pre-existing conditions such as PCOS, or are secondary to the IVF therapy itself.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Presenting with or without PCOS
  • Presenting with structural or mechanical infertility, such as fallopian tube obstruction, endometriosis, fibroids
  • Presenting with male factor
  • Presenting with or without insulin resistance
  • Combination of more than one of the listed above criteria

排除标准

  • Pre-diabetes or diabetes patients (confirmed by impaired or abnormal OGTT)
  • Age above 39 years of age
  • Taking glucose-lowering meds, such as metformin or janumet.
  • Taking corticosteroids

结局指标

主要结局

Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment

时间窗: 12 weeks of pregnancy

Participants who experience an abnormal increase in fasting glucose (\>110) and A1C (\>5.7) will be identified post-treatment. Also, for those previously known to be insulin-resistant, HOMA ratio will help identifying whether the treatment worsens or has no effect on their insulin resistance state.

次要结局

  • Effect of Fertility Medications on Thyroid Function(12 weeks of pregnancy)
  • Effect of Fertility Medications on Lipids Profile(12 weeks of pregnancy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayla Coussa

MSc.

University of Warwick

研究点 (1)

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