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临床试验/NCT04368104
NCT04368104已完成不适用

Endometrial Changes and Fallopian Tubal Darwishscope Test (Office Hysteroscopic Bubble Suction and Tubal Peristalsis) in Women Using Progesterone-only Contraception (POC) as Noticed by Office Hysteroscopy.

Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2021年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
146
试验地点
1
主要终点
office hysteroscopic endometrial and Fallopian tubal Darwishscope test in women using progesterone-only contraception (POC) versus non users of any hormones..

研究概览

简要总结

Mechanisms of action of progesterone-only contraception (POC) include endometrial and Fallopian tubal changes without any scientific documentation. We succeeded to document proper assessment of the proximal part of the Fallopian tubes and test anatomic tubal patency as well (Darwishscope test) via hysteroscopy. This study will test endometrial pattern and Fallopian tubal status in women using progesterone-only contraception (POC) utilizing office hysteroscopy.

详细描述

progesterone-only contraception (POC) prevent pregnancy by thickening the mucus in the cervix to stop sperm reaching an egg and assumed to increase Fallopian tubal motility so the fertilized oocyte reaches the endometrial cavity too early for implantation. However, this assumption has no scientific documentation so far. We succeeded to document visualization of peristalsis of the proximal part of the Fallopian tubes and anatomic tubal patency as well (Darwish test) via hysteroscopy.

Aim of study: to evaluate endometrial pattern and Darwishoscope test (office hysteroscopic bubble suction test and proximal tubal peristalsis) in women using progesterone-only contraception (POC).

Intervention:

It will include women using any form of minipills (Desogestrel 75 µg, or Norethisterone 350 µg), medroxy-progesterone acetate, Merina or implanon complaining from abnormal uterine bleeding in the form of menorrhagia, metorrhagia, intermenstrual spotting or or postcoital bleeding. Cases with suspected endometrial lesion by routine transvaginal follow-up of those cases were also included. They will be assigned as group A. Group B will include women subjected to office hysteroscopy for different indications but not using any form of hormones or systemic or local hormonal contraception. Preoperative counseling of all patients followed by an informed written consent taken from those who will agree. The included patients subjected to complete history taking and meticulous physical examination. A suspected pregnancy, heavy vaginal bleeding, active pelvic inflammatory disease (PID), severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease, and other medical contraindications to pregnancy will be exclusion criteria of this study. Selected cases will be subjected to office hysteroscopy.

Sample size calculation is based on our previous study on the prevalence of tubal peristalsis seen via hysteroscopy. If it is supposed that tubal peristalsis would be positive in about 40% of apparently normal FT and it would be positive in about 80% of cases taking progesterone-only contraception (POC), sample size in each group would be 73 cases in each group. This means 73 or more measurements/surveys are needed to have a confidence level of 90% that the real value is within ±5% of the measured/surveyed value ( α error of 0.05 (the real value is within ±5% of the measured/surveyed value). The vulva, vagina and the thighs will be disinfected with a 10% povidone-iodine solution. Sterile draping will be applied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • women using progesterone-only contraception (POC)
  • women planned for office hysteroscopy for other indication.

排除标准

  • A suspected pregnancy.
  • heavy vaginal bleeding.
  • active pelvic inflammatory disease (PID).
  • severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease
  • Other medical contraindications to pregnancy

结局指标

主要结局

office hysteroscopic endometrial and Fallopian tubal Darwishscope test in women using progesterone-only contraception (POC) versus non users of any hormones..

时间窗: 1 month

case control

次要结局

未报告次要终点

研究者

发起方
Woman's Health University Hospital, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Atef Darwish

Professor of Obstetrics and Gynecology

Woman's Health University Hospital, Egypt

研究点 (1)

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