The Constitution and Efficacy of Chinese Medicine of Infertility Male, Female, and Pregnant Female

Completed

• Conditions: Infertility; Miscarriage Threatening

• Registration Number: NCT06393426
• Lead Sponsor: China Medical University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-06
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-28
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37611

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Temperature of luteal phase	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	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	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	through study completion, an average of 254 days	To determine whether there is a difference in the days of the follicular phase

Secondary Outcome Measures

Name	Time	Method
TCM constitution and pregnancy	through study completion, an average of 254 days	To detect the correlation between TCM constitution and pregnancy

Trial Locations

Locations (1)

CMUH; 🇨🇳 Taichung, Taiwan