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临床试验/NCT03237312
NCT03237312已完成2 期

The Impact of Serum Antimullerian Hormone Level on Adjusting the Number of Ovarian Drills in Polycystic Ovarian Syndrome

Assiut University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Size of ovarian follicle (mm)

研究概览

简要总结

In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. At that time wedge resection of the ovaries was introduced on an empirical basis and proved a successful treatment for the associated anovulation and infertility. In the ensuing fifty years the limitations of a purely surgical approach to therapy have become recognized and the importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary Syndrome: The prevalence of polycystic ovary syndrome in any specified population is dependent upon the diagnostic criteria used, but does have some regional and ethnic variation. While most reports on the prevalence of polycystic ovary syndrome range between 2 and 20%, the chosen diagnostic criteria are recognized to influence the determined prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been done to use the level of anti-mullerian hormone as a factor for planning the number of ovarian drills in each ovary.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Infertility more than 2 years.
  • Age between 20-35 years.
  • clomiphene resistant patients: Patients received clomiphene 150 mg from day 3 to 7 of the menstrual cycle for 6 months and non-ovulatory (with failure of conception). They were followed up in the outpatient clinic.
  • No contraindications for laparoscopy.
  • Normal Hysterosalpingography

排除标准

  • Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect....
  • Women's age less than 20 years or more than 35 years.
  • Previous Laparoscopic surgery.
  • Previous ovarian surgery.
  • Women with Antimullerian hormone level less than 4 ng/ml.
  • Tubal factor infertility as diagnosed by Hysterosalpingography .

研究组 & 干预措施

The study group

Other

The number of ovarian drills was adjusted according to antimullerian hormone level

干预措施: Antimullerian hormone (Biological)

The control group

Other

Four punctures in each ovary were done regardless of the level of antimullerian hormone

干预措施: Laparoscopic ovarian drilling (Procedure)

The control group

Other

Four punctures in each ovary were done regardless of the level of antimullerian hormone

干预措施: Antimullerian hormone (Biological)

The study group

Other

The number of ovarian drills was adjusted according to antimullerian hormone level

干预措施: Laparoscopic ovarian drilling (Procedure)

结局指标

主要结局

Size of ovarian follicle (mm)

时间窗: 14 days

次要结局

  • Antimullerian hormone level (ng/dl)(3 months)
  • Ovarian volume (ml)(3 months)

研究者

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

Mohammed Khairy Ali

Dr

Assiut University

研究点 (2)

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