Clinical trial NCT06393426: The Constitution and Efficacy of Chinese Medicine of Infertility Male, Female, and Pregnant Female
Official title: The Constitution and Efficacy of Chinese Medicine of Infertility Male and Female, and Pregnant Female: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Miscarriage Threatening
Keywords: infertility
Chinese Medicine
miscarriage prevention
retrospective study
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 37611
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Temperature of follicular phase
timeFrame: through study completion, an average of 254 days
measure: Days of follicular phase
timeFrame: through study completion, an average of 254 days
measure: Temperature of luteal phase
timeFrame: through study completion, an average of 254 days
measure: Days of luteal phase
timeFrame: through study completion, an average of 254 days
Secondary outcomes:
measure: TCM constitution and pregnancy
timeFrame: through study completion, an average of 254 days
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: CMUH
Study officials:
References: