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CompletedNCT06393426Updated May 1, 2024

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

An observational study in Infertility and Miscarriage Threatening, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-01.

Sponsored by China Medical University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
37,611
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility
  • Miscarriage Threatening

Keywords

  • infertility
  • Chinese Medicine
  • miscarriage prevention
  • retrospective study
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 37,611 is above the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
37,611 participants (actual)
Patient registry
No

Interventions

  • DrugChinese Herb

    Chinese herbal medicine

06

What researchers measure

Primary outcomes

  1. Temperature of follicular phase

    To determine whether there is a difference in the temperature of the follicular phase

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

  2. Days of follicular phase

    To determine whether there is a difference in the days of the follicular phase

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

  3. Temperature of luteal phase

    To determine whether there is a difference in the temperature of the luteal phase

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

  4. Days of luteal phase

    To determine whether there is a difference in the days of the luteal phase

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

Secondary outcomes

  1. TCM constitution and pregnancy

    To detect the correlation between TCM constitution and pregnancy

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

07

Study locations

1 site
  • CMUH
    Taichung, 404, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06393426
Lead sponsor
China Medical University Hospital
Responsible party
Shan-Yu Su (Attending Physician, Traditional Chinese Medicine Obstetrics and Gynecology, China Medical University Hospital) — Principal investigator
First posted
May 1, 2024
Start date
Jan 1, 2023
Primary completion
May 31, 2023
Completion
May 31, 2023
Last update
May 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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