Infertility, FemalePhase 3NCT03973528
Primary Efficacy Evaluation of Traditional Chinese Medicine in Treating Older Infertile Women
A Phase 3 study testing traditional Chinese medicine: tonifying kidney Wan in people with Infertility, Female, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is a preliminary evaluation of the efficacy of traditional Chinese medicine in the treatment of elderly infertile women. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- traditional Chinese medicine: tonifying kidney Wan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jul 2019to 30 Nov 2021
- Phase
- Phase 3
- 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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- A. Women aged 35-45, married, without contraception, after 12 months of normal sexual life, did not take any contraceptive measures, and did not successfully conceive women.
- Blood tests for serum anti-Mullerian hormone ( AMH) less than 1.2, female hormones FSH, LH, E2 blood test is normal.
- Women who are not planning for IUI or IVF in the next three months. D. Menstrual cycle rules 21-35 days. E. Willing to sign a written consent form.
Who cannot join
- Women with contraceptive. B. Vegetarians or have been taking Traditional Chinese medicine allergies. C. The following diseases have occurred in the past six months: cancer, high blood pressure, diabetes, heart disease, stroke, myocardial infarction, hyperthyroidism or hypothyroidism, chronic hepatitis, gastric ulcer, stomach bleeding, chronic constipation or diarrhea, major trauma and surgery, severe uterine and pelvic infections.
- Because of the need for disease, it is currently necessary to take western medicine for more than three months.
- Women with abnormal liver function (GOT, GPT greater than 2 times the upper limit of normal).
- Women with abnormal renal function (serum creatinine > 1.5 mg/dl). G. Poor compliance with medication. H. In the past month, take a Traditional Chinese medicine to treat infertility. I. Take DHEA for the past month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Evaluation of the Efficacy of Traditional Chinese Medicine in Treating Elderly Women With Infertility
This study is a preliminary evaluation of the efficacy of traditional Chinese medicine in the treatment of elderly infertile women.
Read the detailed description
Research design: initial acceptance of 60 people, 30 in the no intervention group and 30 in the experimental group.
The no intervention group no use Traditional Chinese medicine. The experimental group use Traditional Chinese medicine. Affect natural pregnancy and IVF success factors, the quality of ovarian function plays a very important role. Currently used to predict ovarian follicle inventory indicators, including: age, the total number of small sized ovarian follicles, the first three days of menstrual follicle-stimulating hormone, Anti-Mullerian hormone, inhibin-B.
Research Analysis Chang Gung Memorial Hospital infertility patients using traditional Chinese medicine, more than 40-year-old infertility patients, the most commonly used compound is Zuo Gui Wan. Chinese medicine believes that elderly women with infertility ovulation poor, the main pathogenesis of kidney deficiency. The proportion of domestic infertility patients has increased year by year. Traditional Chinese medicine had become popular and acceptable, but the substantial evidence and treatment consensus of infertility are scanty.
Due to the outbreak of the new crown pneumonia epidemic, which made it difficult to accept the case. Only 17 subjects in the experimental group completed the test. The average age of the subjects was 40.11 ±3.09 years old, and 9 of them were over 40 years old. The AMH before the test was all below 1.2. After three months of treatment with traditional Chinese medicine, 16 subjects had an increase in the number of small sized ovarian follicles. The average total number of small ovarian follicles before the test was 3.06±0.90, and the average increased to 4.53±1.46 after treatment. (P<0.05), which was statistically significant. Eleven subjects showed a decrease in follicle-stimulating hormone on the third day of menstruation after treatment, 9 subjects showed an increase in anti-Mullerian hormone (AMH) value after treatment, and 3 subjects had anti-Mullerian hormone (AMH) values higher than 1.2 after treatment, but they did not reach statistical significance.
- Conditions
- Infertility, Female
- Being tested
- traditional Chinese medicine: tonifying kidney Wan
- Keywords
- anti-Mullerian hormone (AMH), Traditional Chinese Medicine(TCM), Infertility
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Chinese medicine: tonifying kidney WanDrug
Also called tonifying kidney Wan I: Zuo Gui Wan, tonifying kidney Wan II :Guilu Erxian
traditional Chinese medicine : tonifying kidney Wan
| Study group | Role | What they receive |
|---|---|---|
| traditional Chinese medicine | Experimental | The experimental group use traditional Chinese medicine Receives: Drug: traditional Chinese medicine: tonifying kidney Wan |
| non- traditional Chinese medicine | No intervention | The no intervention group no use traditional Chinese medicine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum anti-Mullerian hormone (AMH) index
The efficacy of traditional Chinese medicine in the treatment of infertile women was evaluated by examining serum anti-Mullerian hormone (AMH) index
Measured: three months
total number of small ovarian follicles by the ultrasound examination (menstrual cramps 3-5 days).
The efficacy of traditional Chinese medicine in the treatment of infertile women was evaluated by the total number of small ovarian follicles by the ultrasound examination (menstrual cramps 3-5 days).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start8 Jul 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsang-Tang Hsieh, MD, Study chair, Chang Gung MH IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973528
- Sponsor's protocol ID
- IRB201702097A3
- Other IDs
- Chang Gung MH
- Status last verified
- Mar 2022
- First submitted
- 2 Jun 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Evaluation of the Efficacy of Traditional Chinese Medicine in Treating Elderly Women With Infertility
- ClinicalTrials.gov ID
- NCT03973528
- Acronym / sponsor ID
- IRB201702097A3
- Conditions
- Infertility, Female
- Keywords
- anti-Mullerian hormone (AMH), Traditional Chinese Medicine(TCM), Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 4 Jun 2019 (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.
This study is a preliminary evaluation of the efficacy of traditional Chinese medicine in the treatment of elderly infertile women.
Detailed description
Research design: initial acceptance of 60 people, 30 in the no intervention group and 30 in the experimental group.
The no intervention group no use Traditional Chinese medicine. The experimental group use Traditional Chinese medicine. Affect natural pregnancy and IVF success factors, the quality of ovarian function plays a very important role. Currently used to predict ovarian follicle inventory indicators, including: age, the total number of small sized ovarian follicles, the first three days of menstrual follicle-stimulating hormone, Anti-Mullerian hormone, inhibin-B.
Research Analysis Chang Gung Memorial Hospital infertility patients using traditional Chinese medicine, more than 40-year-old infertility patients, the most commonly used compound is Zuo Gui Wan. Chinese medicine believes that elderly women with infertility ovulation poor, the main pathogenesis of kidney deficiency. The proportion of domestic infertility patients has increased year by year. Traditional Chinese medicine had become popular and acceptable, but the substantial evidence and treatment consensus of infertility are scanty.
Due to the outbreak of the new crown pneumonia epidemic, which made it difficult to accept the case. Only 17 subjects in the experimental group completed the test. The average age of the subjects was 40.11 ±3.09 years old, and 9 of them were over 40 years old. The AMH before the test was all below 1.2. After three months of treatment with traditional Chinese medicine, 16 subjects had an increase in the number of small sized ovarian follicles. The average total number of small ovarian follicles before the test was 3.06±0.90, and the average increased to 4.53±1.46 after treatment. (P<0.05), which was statistically significant. Eleven subjects showed a decrease in follicle-stimulating hormone on the third day of menstruation after treatment, 9 subjects showed an increase in anti-Mullerian hormone (AMH) value after treatment, and 3 subjects had anti-Mullerian hormone (AMH) values higher than 1.2 after treatment, but they did not reach statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional Chinese medicine | Experimental | Drug: traditional Chinese medicine: tonifying kidney WanThe experimental group use traditional Chinese medicine |
| non- traditional Chinese medicine | No intervention | –The no intervention group no use traditional Chinese medicine. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A. Women aged 35-45, married, without contraception, after 12 months of normal sexual life, did not take any contraceptive measures, and did not successfully conceive women.
- Blood tests for serum anti-Mullerian hormone ( AMH) less than 1.2, female hormones FSH, LH, E2 blood test is normal.
- Women who are not planning for IUI or IVF in the next three months. D. Menstrual cycle rules 21-35 days. E. Willing to sign a written consent form.
Key exclusion criteria (4 listed)
- Women with contraceptive. B. Vegetarians or have been taking Traditional Chinese medicine allergies. C. The following diseases have occurred in the past six months: cancer, high blood pressure, diabetes, heart disease, stroke, myocardial infarction, hyperthyroidism or hypothyroidism, chronic hepatitis, gastric ulcer, stomach bleeding, chronic constipation or diarrhea, major trauma and surgery, severe uterine and pelvic infections.
- Because of the need for disease, it is currently necessary to take western medicine for more than three months.
- Women with abnormal liver function (GOT, GPT greater than 2 times the upper limit of normal).
- Women with abnormal renal function (serum creatinine > 1.5 mg/dl). G. Poor compliance with medication. H. In the past month, take a Traditional Chinese medicine to treat infertility. I. Take DHEA for the past month.
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 |
|---|---|---|
| traditional Chinese medicine: tonifying kidney WanAlso: tonifying kidney Wan I: Zuo Gui Wan, tonifying kidney Wan II :Guilu Erxiantraditional Chinese medicine : tonifying kidney Wan | Drug | traditional Chinese medicine |
Primary outcome
serum anti-Mullerian hormone (AMH) index
Time frame: three months
The efficacy of traditional Chinese medicine in the treatment of infertile women was evaluated by examining serum anti-Mullerian hormone (AMH) index
total number of small ovarian follicles by the ultrasound examination (menstrual cramps 3-5 days).
Time frame: three months
The efficacy of traditional Chinese medicine in the treatment of infertile women was evaluated by the total number of small ovarian follicles by the ultrasound examination (menstrual cramps 3-5 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 22 Mar 2022.
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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.
Tsang-Tang Hsieh, MD study chair
Chang Gung MH IRB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing traditional Chinese medicine: tonifying kidney Wan in people with Infertility, Female, run by Chang Gung Memorial 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 3 inclusion and 4 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 22 Mar 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
serum anti-Mullerian hormone (AMH) index (time frame: three months). The study lists 2 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 22 Mar 2022.