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临床试验/NCT02499289
NCT02499289Unknown不适用

Does Prolonged Fasting Break the Vicious Circle of Polycystic Ovarian Syndrome of Insulin Resistance ?

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
spontaneous ovulation measured by midluteal progesterone

研究概览

简要总结

Polycystic ovary syndrome (PCOS) has a heterogeneous clinical presentation comprising reproductive (hyperandrogenism, menstrual irregularity, anovulation, infertility, pregnancy complications), metabolic [insulin resistance (IR), increased type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) risk factors] and psychological features (worsened quality of life and increased anxiety and depression) Whether prolonged fasting during Ramadan breaks the insulin resistance state of polycystic ovarian syndrome and subsequently improve the ovulation and spontaneous pregnancy will happen without ovarian stimulation.

详细描述

Question of the study:

The question is raised whether prolonged fasting during Ramadan breaks the insulin resistance state of polycystic ovarian syndrome and improve the metabolic syndrome does prolonged fasting decrease glucose level, insulin level, insulin resistance markers such as adipokines and subsequently improve ovarian function and causes spontaneous ovulation.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Females with PCO in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital, and welling to fast for 30 days from 5 am until 7 pm and do not plan to induce her ovulation in the next 4 months to get pregnant.
  • Does not have any other medical illnesses other than PCO.
  • Welling not to start any ovulation induction in the next 4 months after the first blood sample was taken and after fasting month.

排除标准

  • Known androgen secreting tumor.
  • PCO on ovarian stimulation medications
  • PCO with any other medical illness.
  • Non-compliance with fasting 30 days from 5 am- 7 pm.

结局指标

主要结局

spontaneous ovulation measured by midluteal progesterone

时间窗: one month

Ovulation will be monitored by the Progesterone level on 22nd day of first cycle after 30 days of prolonged daily Fasting (Ramadan).

次要结局

  • fasting glucose/insuline ratio(one month)
  • plasma gherlin(one month)
  • clinical pregnancy(four months)
  • plasma resistin(one month)
  • Plasma adiponectin(one month)

研究者

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

Ahmed Mohamed El Kotb Abdel Fattah

Dr. Ahmed Kotb

Ain Shams University

研究点 (1)

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