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临床试验/NCT02762097
NCT02762097撤回3 期

Clinical Pregnancy Rate in Women With Unexplained Infertility After Removal of Unsuspected Intrauterine Pathology

Karachi Medical and Dental College0 个研究点开始时间: 2017年1月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回
发起方
主要终点
Clinical pregnancy rate:

研究概览

简要总结

Polyps are fleshy outgrowths of the inner lining of the womb which may hinder implantation of embryo and lead to subfertility.This study evaluates whether removal of endometrial polyps in womb affects chances of pregnancy in women in whom no other causes of subfertility can be found. Half of the women would have these polyps removed after their consent and the other half who would not consent would not undergo any such intervention

研究设计

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

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

  • Normal semen analysis
  • 24 months of unprotected sexual intercourse
  • NORMAL TVS
  • Normal hysterosalpingogram
  • Evidence of spontaneous ovulation
  • No history of Pelvic inflammatory disease
  • Polyps on saline sonography

排除标准

  • History of taking hormones
  • Thyroid disorder
  • prior hysteroscopy treatment
  • intermenstrual blood loss.

研究组 & 干预措施

intervention

Experimental

All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy

干预措施: polypectomy (Procedure)

intervention

Experimental

All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy

干预措施: saline sonography (Procedure)

intervention

Experimental

All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy

干预措施: normal saline (Drug)

control

Placebo Comparator

All women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls

干预措施: saline sonography (Procedure)

control

Placebo Comparator

All women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls

干预措施: normal saline (Drug)

结局指标

主要结局

Clinical pregnancy rate:

时间窗: 12 months

number of women who get pregnancy test positive within 12 months of intervention

次要结局

未报告次要终点

研究者

发起方
Karachi Medical and Dental College
申办方类型
Other
责任方
Principal Investigator
主要研究者

samia husain

research assistant

Karachi Medical and Dental College

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