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

April 28, 2024 updated by: Shan-Yu Su, China Medical University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

37611

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • CMUH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who met the following criteria, from 2015 to 2020, were reported by various medical institutions across Taiwan into the National Health Insurance database for the Traditional Chinese Medicine Enhancement of Maternity Care Quality Project.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature of follicular phase
Time Frame: through study completion, an average of 254 days
To determine whether there is a difference in the temperature of the follicular phase
through study completion, an average of 254 days
Days of follicular phase
Time Frame: through study completion, an average of 254 days
To determine whether there is a difference in the days of the follicular phase
through study completion, an average of 254 days
Temperature of luteal phase
Time Frame: through study completion, an average of 254 days
To determine whether there is a difference in the temperature of the luteal phase
through study completion, an average of 254 days
Days of luteal phase
Time Frame: through study completion, an average of 254 days
To determine whether there is a difference in the days of the luteal phase
through study completion, an average of 254 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TCM constitution and pregnancy
Time Frame: through study completion, an average of 254 days
To detect the correlation between TCM constitution and pregnancy
through study completion, an average of 254 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

April 6, 2024

First Submitted That Met QC Criteria

April 28, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH111-REC2-085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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