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

NCT06393426 | Completed

• 1 other identifier: CMUH111-REC2-085
• Study Type: observational
• Target: 37,611
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Miscarriage Threatening

Keywords

infertility; Chinese Medicine; miscarriage prevention; retrospective study

Outcome Measures

Primary Outcomes (4)

• Temperature of follicular phase

  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

  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

  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

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

  through study completion, an average of 254 days

Secondary Outcomes (1)

• TCM constitution and pregnancy

  through study completion, an average of 254 days

Interventions

Chinese Herb DRUG

Chinese herbal medicine

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

CMUH

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Infertility; Abortion, Threatened

Interventions

Ephedrae herba

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Traditional Chinese Medicine Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: May 1, 2024
• Study Start: January 1, 2023
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)