The Constitution and Efficacy of Chinese Medicine of Infe... | NCT06393426

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

NCT06393426

Sponsor

China Medical University Hospital

Status

Completed

Last Update Posted

May 1, 2024Actual

Enrollment

37,611Actual

Phase

Not provided

Conditions

Infertility
Miscarriage Threatening

Interventions

Chinese Herb

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

May 31, 2023Actual

Completion Date

May 31, 2023Actual

First Submitted Date

Apr 6, 2024

First Submission Date that Met QC Criteria

Apr 28, 2024

First Posted Date

May 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2024

Last Update Posted Date

May 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shan-Yu Su, Attending Physician, Traditional Chinese Medicine Obstetrics and Gynecology, China Medical University HospitalPrincipal Investigator

Lead Sponsor

China Medical University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37,611Actual

Name	Type	Description	Arm Group Labels	Other Names
Chinese Herb	Drug	Chinese herbal medicine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CMUH		Taichung		404	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D000033	Abortion, Threatened

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

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