Failure After Assisted Reproductive TechnologyPhase 2NCT02303665
Observing the Curative Effect of Assisted Reproduction by TCM Multi-channel Interventional Therapy
A Phase 2 study testing The dual therapy and The triple therapy in people with Failure After Assisted Reproductive Technology, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on women with ART Failure; to compare the curative effect of the dual therapy and triple therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan. Read more about this study
- Who is it for?
- Ages 24 to 43 years, women only
- Conditions the study is for
- Failure After Assisted Reproductive Technology
- What is being tested?
- The dual therapy and The triple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Mar 2016
- Phase
- Phase 2
- 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 24 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- People aged 20 to 45
- People with IVF - ET indications
- People from Reproductive Center of West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) with long plan for IVE - ET Failure and then accept the secondary IVF-ET
- People who conform to the standard of syndrome differentiation in TCM: kidney deficiency and liver depression and blood stasis
- People with normal basic sex hormone levels
- People who have recognized and voluntarily signed the informed consent. NOTICE: People who conform to the above 6 items can be included.
Who cannot join
- People don't meet the inclusion criteria
- The husband with less sperm and weak sperm seriously
- People who have drug allergy or allergic constitution
- People with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, etc. And mentally disordered patients
- People who are complicated by acute infectious diseases and organic diseases
- People have confirmed diagnosis malformed reproductive organs, reproductive system inflammation and tumors upon examination
Show all 9Show fewer
- People suffer from hereditary disease which is not suitable for fertility regulated in "maternal and infant health care law"
- People who have the serious bad habits such as drug use
- People who have contacted with birth defects rays, poison, drugs to a certain number and being in effect; NOTICE: People who conform to any of the terms above 9 will be ruled out.
Trial locations and contacts
1 site in 1 country.
China1 site
West China second University Hospital of Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: TCM Multi-channel Interventional Therapy for Assisting Reproduction
Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on women with ART Failure; to compare the curative effect of the dual therapy and triple therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan.
Methods: The cases with ART Failure from West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) meeting the inclusion criteria were randomly divided into three groups: the dual therapy group, the triple therapy group and the control group, compare the natural pregnancy number, the condition during the period of secondary IVF-ET and the improvement of the kidney deficiency, liver depression and blood stasis syndrome among those three groups.
Read the detailed description
Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on women with ART Failure; to compare the curative effect of the dual therapy and triple therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan.
Methods: The cases with ART Failure from West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) meeting the inclusion criteria were randomly divided into three groups: the dual therapy group, the triple therapy group and the control group, compare the natural pregnancy number, the condition during the period of secondary IVF-ET and the improvement of the kidney deficiency, liver depression and blood stasis syndrome among those three groups.
The results will show the effect of TCM multi-channel interventional therapy for patients with ART failure
- Being tested
- The dual therapy, The triple therapy
- Keywords
- TCM multi-channel therapy, ART failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The dual therapyOther
TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy
The triple therapyOther
TCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM
| Study group | Role | What they receive |
|---|---|---|
| The control group | No intervention | No Intervention |
| The dual therapy group | Experimental | TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy. Receives: Other: The dual therapy |
| The triple therapy group | Experimental | TCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM. Receives: Other: The triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with sucessful conception
Measured: 10 weeks after embryo transplantation
Secondary outcomes (2)
Time to have successful conception
Measured: up to 26 weeks
Adverse events
Measured: 0, 10, 26 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure After Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Jinzhu, Chengdu University of Traditional Chinese Medicine
- Investigators
- Qian Zeng, Study director, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303665
- Sponsor's protocol ID
- 2012SZ0086
- Status last verified
- Mar 2017
- First submitted
- 21 Nov 2014
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCM Multi-channel Interventional Therapy for Assisting Reproduction
- ClinicalTrials.gov ID
- NCT02303665
- Acronym / sponsor ID
- 2012SZ0086
- Keywords
- TCM multi-channel therapy, ART failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Dec 2014 (estimated)
- 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.
Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on women with ART Failure; to compare the curative effect of the dual therapy and triple therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan.
Methods: The cases with ART Failure from West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) meeting the inclusion criteria were randomly divided into three groups: the dual therapy group, the triple therapy group and the control group, compare the natural pregnancy number, the condition during the period of secondary IVF-ET and the improvement of the kidney deficiency, liver depression and blood stasis syndrome among those three groups.
Detailed description
Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on women with ART Failure; to compare the curative effect of the dual therapy and triple therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan.
Methods: The cases with ART Failure from West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) meeting the inclusion criteria were randomly divided into three groups: the dual therapy group, the triple therapy group and the control group, compare the natural pregnancy number, the condition during the period of secondary IVF-ET and the improvement of the kidney deficiency, liver depression and blood stasis syndrome among those three groups.
The results will show the effect of TCM multi-channel interventional therapy for patients with ART failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The control group | No intervention | –No Intervention |
| The dual therapy group | Experimental | Other: The dual therapyTCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy. |
| The triple therapy group | Experimental | Other: The triple therapyTCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM. |
Who may qualify
- Ages
- 24 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- People aged 20 to 45
- People with IVF - ET indications
- People from Reproductive Center of West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) with long plan for IVE - ET Failure and then accept the secondary IVF-ET
- People who conform to the standard of syndrome differentiation in TCM: kidney deficiency and liver depression and blood stasis
- People with normal basic sex hormone levels
Key exclusion criteria (9 listed)
- People don't meet the inclusion criteria
- The husband with less sperm and weak sperm seriously
- People who have drug allergy or allergic constitution
- People with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, etc. And mentally disordered patients
- People who are complicated by acute infectious diseases and organic diseases
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 |
|---|---|---|
| The dual therapyTCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy | Other | The dual therapy group |
| The triple therapyTCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM | Other | The triple therapy group |
Primary outcome
Proportion of patients with sucessful conception
Time frame: 10 weeks after embryo transplantation
2 secondary outcomes
Time to have successful conception
Time frame: up to 26 weeks
Adverse events
Time frame: 0, 10, 26 weeks after randomization
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 10 Mar 2017.
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.
Qian Zeng study director
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The dual therapy and The triple therapy in people with Failure After Assisted Reproductive Technology, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
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 6 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 10 Mar 2017. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of patients with sucessful conception (time frame: 10 weeks after embryo transplantation). 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 10 Mar 2017.