Skip to main content
OpenTrials
Completed

NCT Number: NCT06393426

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Abortion, Threatened Female Urogenital Diseases and Pregnancy Complications Genital Diseases Miscarriage Threatening Pregnancy Complications Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CMUH

Taichung, 404, Taiwan

About this study

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:

  • Paired-t Test: Examining differences in temperature and duration between follicular and luteal phases in females before and after treatment.
  • Chi-Square Test: Assessing the relationship between traditional Chinese medicine constitution and pregnancy outcomes.
  • McNemar Test: Testing the significance of changes in traditional Chinese medicine constitution before and after treatment.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Chinese Herb

Drug

Chinese herbal medicine

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. TCM constitution and pregnancy

    Time frame: through study completion, an average of 254 days

    To detect the correlation between TCM constitution and pregnancy

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 1, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.