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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06393426
Other study ID # CMUH111-REC2-085
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date May 31, 2023

Study information

Verified date April 2024
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 37611
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Fertility Assistance: 1. Incomplete demographic data for males/females 2. Incomplete Traditional Chinese Medicine constitution determination data for males/females 3. Incomplete information on the follicular/luteal phase for females 4. Incomplete semen analysis data for males - Miscarriage Prevention: 1. Incomplete demographic data 2. Incomplete physiological examination data 3. Incomplete data on related disease records

Study Design


Intervention

Drug:
Chinese Herb
Chinese herbal medicine

Locations

Country Name City State
Taiwan CMUH Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Temperature of follicular phase To determine whether there is a difference in the temperature of the follicular phase through study completion, an average of 254 days
Primary Days of follicular phase To determine whether there is a difference in the days of the follicular phase through study completion, an average of 254 days
Primary Temperature of luteal phase To determine whether there is a difference in the temperature of the luteal phase through study completion, an average of 254 days
Primary Days of luteal phase To determine whether there is a difference in the days of the luteal phase through study completion, an average of 254 days
Secondary TCM constitution and pregnancy To detect the correlation between TCM constitution and pregnancy through study completion, an average of 254 days
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