Primary Female InfertilityTCM-P002NCT01331395
Effect of Traditional Chinese Medicine on In Vitro Fertilization (IVF) Success Rates
A study testing Traditional Chinese Medicine in people with Primary Female Infertility and Secondary Female Infertility, run by Pacific Fertility Center.
Trial summary
The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF). Read more about this study
- Who is it for?
- Ages 21 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Female Infertility, Secondary Female Infertility
- What is being tested?
- Traditional Chinese Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2013
- Phase
- Interventional
- 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 21 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is able to understand and provide consent
- Subject is female, 21-42 years of age at time of screening and has at least one l ovary
- Subject BMI is > 18 and < 32
- Subject is experiencing primary or secondary infertility
- Subject may receive sperm from donated source
- Subject's partner has sperm in the ejaculate
Show all 13Show fewer
- Subject's serum basal FSH is < 11 IU/L
- Subject's serum basal estradiol level is between 20-80 pg/mL
- Subject's TSH level is < 3.0 mv/mL
- Subject's prolactin level is < 24 ng/mL
- Subject will agree to limit caffeine intake to one cup (76.5 mL/day) by the time of randomization
- Subject agrees not to make alterations in diet and lifestyle practices other than those that their Medical Practitioner deems necessary in the best interest of the subject
- Subject agrees not to participate in any other research opportunities for the duration of the study
Who cannot join
- Subject is pursuing sex selection
- Subject is undergoing treatment with an egg donor
- Subject experienced more than 2 previous failed cycles
- Subject is undergoing a heparin or lovenox-based protocol
- Subject is currently taking herbal therapy (1 week wash-out)
- Subject is currently taking co-interventions of moxibustion and cupping
Show all 11Show fewer
- Subject is exhibiting uterine anomalies (i.e.,bicornuate, unicornuate uterus,)
- Subject is diagnosed with severe endometriosis defined as endometriomas > 4cm
- Subject is currently receiving acupuncture therapy (Subject must agree to a 30 day washout period prior to randomization)
- Subject has history of recurrent spontaneous abortions defined as > 3
- Subjects with a Beck Depression Inventory (BDI-II) of 29 or higher at screening, indicative of severe depression, will be excluded from the study and referred for further psychological evaluation by our in-house licensed mental health professional.
About this study
Official title: A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates
The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).
- Being tested
- Traditional Chinese Medicine
- Keywords
- Infertility, IVF, Acupuncture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese MedicineOther
Also called Acupuncture
Active arm will receive Acupuncture with their IVF cycle.
| Study group | Role | What they receive |
|---|---|---|
| IVF-No Acupuncture | No intervention | IVF with no Traditional Chinese Medicine: Acupuncture |
| IVF-Acupuncture | Active comparator | IVF with Traditional Chinese Medicine: Acupuncture Receives: Other: Traditional Chinese Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who receive an embryo transfer which results in a live birth.
Embryo transfer resulting in Live Birth up to 40 weeks gestation
Measured: Average of 1 year
The proportion of subjects in the active treatment group experiencing no SAE's attributable to ACU.
Measured: Overall to be collected at interim analysis of 138 subjects and at study completion of 276 patients
Secondary outcomes (2)
1. The proportion of subjects who undergo an embryo transfer which results in implantation as evidenced by USS at 7 weeks.
At 7 week ultrasound
Measured: Average of 4 months
Effect of the IVF/ICSI treatment on quality of life and psychological factors assessed with the Fertility Quality of Life Questionnaire (FertiQoL 2008) and the Spielberger State Trait Anxiety Inventory (STAI).
Repeat measures at Screening, Treatment Month and at Embryo Transfer
Measured: Average of two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Enrollment rate slower than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Female InfertilityStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eldon Schriock, MD, Principal investigator, Pacific Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331395
- Sponsor's protocol ID
- 2010.097-1 (Esch)
- Acronym
- TCM-P002
- Status last verified
- Oct 2015
- First submitted
- 4 Apr 2011
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates
- ClinicalTrials.gov ID
- NCT01331395
- Acronym / sponsor ID
- TCM-P002 / 2010.097-1 (Esch)
- Keywords
- Infertility, IVF, Acupuncture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment rate slower than anticipated.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pacific Fertility CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Apr 2011 (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.
The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF-No Acupuncture | No intervention | –IVF with no Traditional Chinese Medicine: Acupuncture |
| IVF-Acupuncture | Active comparator | Other: Traditional Chinese MedicineIVF with Traditional Chinese Medicine: Acupuncture |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subject is able to understand and provide consent
- Subject is female, 21-42 years of age at time of screening and has at least one l ovary
- Subject BMI is > 18 and < 32
- Subject is experiencing primary or secondary infertility
- Subject may receive sperm from donated source
Key exclusion criteria (11 listed)
- Subject is pursuing sex selection
- Subject is undergoing treatment with an egg donor
- Subject experienced more than 2 previous failed cycles
- Subject is undergoing a heparin or lovenox-based protocol
- Subject is currently taking herbal therapy (1 week wash-out)
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 MedicineAlso: AcupunctureActive arm will receive Acupuncture with their IVF cycle. | Other | IVF-Acupuncture |
Primary outcome
The proportion of subjects who receive an embryo transfer which results in a live birth.
Time frame: Average of 1 year
Embryo transfer resulting in Live Birth up to 40 weeks gestation
The proportion of subjects in the active treatment group experiencing no SAE's attributable to ACU.
Time frame: Overall to be collected at interim analysis of 138 subjects and at study completion of 276 patients
2 secondary outcomes
1. The proportion of subjects who undergo an embryo transfer which results in implantation as evidenced by USS at 7 weeks.
Time frame: Average of 4 months
Effect of the IVF/ICSI treatment on quality of life and psychological factors assessed with the Fertility Quality of Life Questionnaire (FertiQoL 2008) and the Spielberger State Trait Anxiety Inventory (STAI).
Time frame: Average of two months
Results and safety
The study was stopped early (reason given: Enrollment rate slower than anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Related InfoLink provided by the sponsor.
Related trials for Primary Female Infertility
Not yet recruitingPhase 3
Progesterone Luteal Support in Unexplained Infertility Management
Infertility, Female Infertility
Not yet recruiting
Ovarian Tissue Allo-transplantation
Ovarian Failure, Ovarian Insufficiency
Active, not recruiting
Ovarian PRP (Platelet Rich Plasma) Injection for Follicular Activation
Premature Ovarian Insufficiency, Infertility, Female
RecruitingObservational study
Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
Infertility, Female, Premature Ovarian Failure
RecruitingObservational study
Polycystic Ovary Syndrome, Mitochondrial Dysfunction, Obesity, Insulin Resistance Infertility (POMODORI) Cohort
Infertility, Female, Polycystic Ovary Syndrome
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.
Eldon Schriock, MD principal investigator
Pacific Fertility Center
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese Medicine in people with Primary Female Infertility and Secondary Female Infertility, run by Pacific Fertility Center.
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 13 inclusion and 11 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: stopped early, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Enrollment rate slower than anticipated.). Results are not available in the source record.
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?
The proportion of subjects who receive an embryo transfer which results in a live birth. (time frame: Average of 1 year). 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 29 Oct 2015.