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

NCT ID: NCT06393426

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37611 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-05-31

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.

Conditions

Infertility; Miscarriage Threatening

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Chinese Herb

Chinese herbal medicine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shan-Yu Su

Attending Physician, Traditional Chinese Medicine Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CMUH

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH111-REC2-085

Identifier Type: -

Identifier Source: org_study_id