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临床试验/NCT02568488
NCT02568488已完成4 期

The Effect of Metformin on Serum Insulin, Androgens and AMH in PCOS Patients

Ahmed Maged0 个研究点目标入组 48 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
48
主要终点
hormonal changes

研究概览

简要总结

Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:

  1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks),
  2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels
  3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).

the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months. Blood samples were collected at the start of the study, before receiving metformin, where baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) , total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and 6 months respectively of metformin treatment , to asses its effect on serum levels of the previously mentioned hormonal parameters.

详细描述

Forty eight PCOS patients attending the OBGYN clinic at kasr al aini were included in the study. The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:

  1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks),
  2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels
  3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).

the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months. Blood samples were collected at the start of the study, before receiving metformin, where baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) , total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and 6 months respectively of metformin treatment , to asses its effect on serum levels of the previously mentioned hormonal parameters.

The effect of metformin on PCOS patients regarding its clinical and radiological parameters was also assessed. Each patient was asked to keep a diary of her menstrual periods over the study period; to elicit if there could be an effect by metformin on the regulation of menstrual cycles secondary to improvement of ovarian function as a result of improving insulin resistance in such patients. The effect of metformin on ovarian morphology by ultrasound was also assessed at baseline, 3months and 6 months of the study period; ovarian volume and number of follicles was noted down at each visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 33 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Non pregnant PCOS patients .
  • The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:
  • history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks),
  • infertility with hirsutism or acne or elevation of one or more of serum androgen levels
  • ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).

排除标准

  • those with prior history of glucose intolerance,
  • history of gestational diabetes,
  • NIDDM patients,
  • cushing's syndrome,
  • thyroid dysfunction,
  • hyperprolactinemia,
  • congenital adrenal hyperplasia
  • patients on prolonged corticosteroid course, or other medications that alter the hormonal or metabolic profile; including PCOS patients who were on OCPs or cyclic progestagens

研究组 & 干预措施

metformin

Experimental

PCOS women receiving metformin 850 mg orally twice daily over a period of 6 months

干预措施: Metformin (Drug)

结局指标

主要结局

hormonal changes

时间窗: Change from Baseline at 3 and 6 months

total and free testosterone

次要结局

  • sex hormone binding globulin (SHBG)(Change from Baseline at 3 and 6 months)
  • serum insulin levels(Change from Baseline at 3 and 6 months)
  • Antimullerian Hormone (AMH)(Change from Baseline at 3 and 6 months)
  • Dihydroepiandrostenedione sulphate (DHEAS)(Change from Baseline at 3 and 6 months)
  • ovarian morphology(Change from Baseline at 3 and 6 months)

研究者

发起方
Ahmed Maged
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Maged

Assistant professor

Cairo University

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