InfertilityNCT06393426
The Constitution and Efficacy of Chinese Medicine of Infertility Male, Female, and Pregnant Female
An observational study of Infertility and Miscarriage Threatening, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, Miscarriage Threatening
- What is being tested?
- Chinese Herb
- How many people
- 37,611 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 9Show fewer
- Incomplete demographic data
- Incomplete physiological examination data
- Incomplete data on related disease records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Constitution and Efficacy of Chinese Medicine of Infertility Male and Female, and Pregnant Female: a Retrospective Study
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:
- 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.
- Conditions
- Infertility, Miscarriage Threatening
- Being tested
- Chinese Herb
- Keywords
- infertility, Chinese Medicine, miscarriage prevention, retrospective study
- Medical subject headings
- Infertility, Abortion, Threatened
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese HerbDrug
Chinese herbal medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature of follicular phase
To determine whether there is a difference in the temperature of the follicular phase
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 254 days
Secondary outcomes (1)
TCM constitution and pregnancy
To detect the correlation between TCM constitution and pregnancy
Measured: through study completion, an average of 254 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Jan 2023
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 37,611 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shan-Yu Su, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393426
- Sponsor's protocol ID
- CMUH111-REC2-085
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Constitution and Efficacy of Chinese Medicine of Infertility Male and Female, and Pregnant Female: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06393426
- Acronym / sponsor ID
- CMUH111-REC2-085
- Conditions
- Infertility, Miscarriage Threatening
- Keywords
- infertility, Chinese Medicine, miscarriage prevention, retrospective study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,611 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- Fertility Assistance:
- Miscarriage Prevention:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese HerbChinese herbal medicine | Drug | – |
Primary outcome
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
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
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
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
1 secondary outcome
TCM constitution and pregnancy
Time frame: through study completion, an average of 254 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Miscarriage Threatening, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature of follicular phase (time frame: through study completion, an average of 254 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.