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临床试验/NCT06393426
NCT06393426已完成不适用

The Constitution and Efficacy of Chinese Medicine of Infertility Male and Female, and Pregnant Female: a Retrospective Study

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 37,611 人开始时间: 2023年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
37,611
试验地点
1
主要终点
Temperature of luteal phase

研究概览

简要总结

The project aims to conduct a retrospective study to assess the impact of Traditional Chinese Medicine (TCM) on improving pregnancy rates and preventing miscarriages. It will include patients with infertility issues or a history of miscarriage. The study will analyze demographic and physiological data, TCM constitution, basal body temperature, reproductive history for females, and semen analysis for males, to determine the effectiveness of TCM care in enhancing fertility outcomes.

详细描述

The present project plans to conduct a retrospective study based on the data of the National Health Insurance Traditional Chinese Medicine Enhancement Quality of Maternity Care Plan.

Analysis Methods: The collected data was archived using SPSS software, and the following testing methods were employed for statistical analysis among different datasets:

  1. Paired-t Test: Examining differences in temperature and duration between follicular and luteal phases in females before and after treatment.
  2. Chi-Square Test: Assessing the relationship between traditional Chinese medicine constitution and pregnancy outcomes.
  3. McNemar Test: Testing the significance of changes in traditional Chinese medicine constitution before and after treatment.
  4. Logistic Regression: Conducting multivariate analysis to explore factors associated with pregnancy status.

The purpose of this project is to figure out after conducting proper Chinese medical care, whether it will improve the target patients' pregnancy rate and miscarriage prevention rate. Those data will conduct a biological analysis to compare the difference between pregnancy and miscarriage prevention rates between different patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Fertility Assistance: For male and female patients who have been married for over a year with regular sexual activity but are unable to conceive.
  • Miscarriage Prevention: For females who have had miscarriages, non-natural conception, conception through fertility assistance, and are prone to miscarriage.

排除标准

  • Fertility Assistance:
  • Incomplete demographic data for males/females
  • Incomplete Traditional Chinese Medicine constitution determination data for males/females
  • Incomplete information on the follicular/luteal phase for females
  • Incomplete semen analysis data for males
  • Miscarriage Prevention:
  • Incomplete demographic data
  • Incomplete physiological examination data
  • Incomplete data on related disease records

结局指标

主要结局

Temperature of luteal phase

时间窗: through study completion, an average of 254 days

To determine whether there is a difference in the temperature of the luteal phase

Days of luteal phase

时间窗: through study completion, an average of 254 days

To determine whether there is a difference in the days of the luteal phase

Temperature of follicular phase

时间窗: through study completion, an average of 254 days

To determine whether there is a difference in the temperature of the follicular phase

Days of follicular phase

时间窗: through study completion, an average of 254 days

To determine whether there is a difference in the days of the follicular phase

次要结局

  • TCM constitution and pregnancy(through study completion, an average of 254 days)

研究者

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

Shan-Yu Su

Attending Physician, Traditional Chinese Medicine Obstetrics and Gynecology

China Medical University Hospital

研究点 (1)

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