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临床试验/NCT03412487
NCT03412487Unknown不适用

Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure and Its Relation to Thyroid Dysfunction

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
presence of autoimuune oophoritis

研究概览

简要总结

25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).

*Pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation

For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody

详细描述

25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).Pelvic laparoscopy and ovarian biopsy To be examined histologically. All procedures were performed under general anesthesia the utero-ovarian ligament was stabilized with the round biopter introduced through the other. The round metal biopter 5 mm in diameter with an inner protective trocar.

The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness. The round biopter was removed, and a grasper was introduced to recover the excised tissue.

Ovarian biopsy specimens were fixed in 10% formalin and embedded in paraffin forming tissue blocks. Two sections, 4μ thick were cut from each block. One was stained with routine haematoxylin and eosin (H&E) stain while the other was immunostained with anti-Leukocyte Common Antigen (LCA).

For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • Woman under age of 40y.
  • Infertility.
  • History of oligomenorrhea or amenorrhea for 1 year or more FSH level >20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure).
  • History of thyroid dysfunction, postpartum thyroiditis and or thyroid surgery.
  • Symptoms or signs suggestive of thyroid dysfunction or goiter.
  • Family history of thyroid dysfunction or goiter.
  • Presence of thyroid antibodies or other antibodies.
  • Type 1 Diabetes Mellitus.
  • Prior irradiation to head and neck

排除标准

  • Women above 40 yrs.
  • Follicle stimulating hormone (FSH) less than 20mIU/mL
  • Women using hormonal treatement, exposed to radiation to abdomen or pelvis, chemotherapy, or ovarian surgery.

研究组 & 干预措施

premature ovarian failure

Active Comparator

women under 40 years old with History of oligomenorrhea or amenorrhea for 1 year or more FSH level >20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure).

干预措施: laparoscopy (Procedure)

Control group

Active Comparator

A group of female patients presented with infertility but with regular menses and normal ovarian function (according to history, general examination, gynecological examination and FSH level).

干预措施: laparoscopy (Procedure)

结局指标

主要结局

presence of autoimuune oophoritis

时间窗: at time of laproscopy procedure

Autoimmune oophritis was assessed by quantifying LCA positive cells in ovarian stroma as follows: \[Type text\] 0= not convincing. 1. mild autoimmune oophritis. 2. moderate autoimmune oophritis. 3. sever autoimmune oophritis.

次要结局

未报告次要终点

研究者

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

Ahmed Maged

professor

Cairo University

研究点 (2)

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