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临床试验/NCT03486626
NCT03486626Unknown4 期

Endometrial Thickness And Subendometrial Vascularity In Anovulatory Polycystic Ovarian Syndrome Patients Treated by Metformin

Ain Shams Maternity Hospital1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2018年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
85
试验地点
1
主要终点
pregnancy

研究概览

简要总结

The participants will receive metformin 500mg 3times per day for 3months and one month is left for spontaneous pregnancy to occur or not (primary outcome ) and the investigators will check endometrial thickness and subendometerial vascularity as markers of endometrial receptivity before and after the treatment.

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • PCO syndrome patients have the following criteria:
  • Age of the patient between 20 - 40 years old. All subjects are not on a specific diet nor a certain program of physical exercise Complaining of infertility either primary or secondary due to PCOS.
  • N.B: The diagnosis of PCO syndrome was made according to the Androgen Excess and Polycystic Ovarian Syndrome Society: the presence of the following criteria have been required for the diagnosis of PCO syndrome:
  • Hyperandrogenism: Hirsutism and/or Hyperandrogenaemia Ovarian Dysfunction : Oligo-Anovulation and /or Polycystic ovaries Exclusion of other Androgen Excess or related disorders as :( deficient nonclassic adrenal hyperplasia, androgen-secreting neoplasms, androgenic/anabolic drug use or abuse, Cushing's syndrome, the Hyperandrogenic-Insulin Resistance-Acanthosis Nigricans syndrome, thyroid dysfunction, and hyperprolactinemia).

排除标准

  • Age below 20 or above
  • Women who intended to start a diet or a specific program of physical activity. Concurrent medical illness as cardiovascular, neoplastic and hepatic disorder. Pelvic pathology. Tubal, Uterine, Male factor of infertility. Endocrinological factors including: diabetes Mellitus,hypothyroidism, hyperprolactinaemia, Cushing's syndrome, and non- classical congenital adrenal hyperplasia.
  • Patients who are ovulatory during the ovarian cycle

研究组 & 干预措施

Patients

Experimental

干预措施: Metformin (Drug)

结局指标

主要结局

pregnancy

时间窗: 4 months

polycystic ovarian syndrome patients getting pregnant on receiving Metformin

次要结局

  • Endometrial thickness and Sub Endometrial vascularity(4 months)

研究者

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

Mohamed Adel mohamed kamal Eldin Abdelrahman

Resident of Obstetrics and gynecology

Ain Shams Maternity Hospital

研究点 (1)

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