Supervision of Pregnancy Resulting From In-vitro FertilizationNCT01608048
Transcutaneous Electrical Acupoint Stimulation to Improve Pregnancy Rates for Women Undergoing in Vitro Fertilization
A study testing transcutaneous electrical acupoint stimulation (TEAS);EA in people with Supervision of Pregnancy Resulting From In-vitro Fertilization, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The objective of this study is to investigate the effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Supervision of Pregnancy Resulting From In-vitro Fertilization
- What is being tested?
- transcutaneous electrical acupoint stimulation (TEAS);EA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Feb 2017
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertile women < 40 years of age, undergoing a fresh IVF or intracytoplasmic sperm injection (ICSI) cycle; (2) be an appropriate candidate with the potential for a lower success rate which defined as two or more previous unsuccessful ETs (fresh or frozen); (3) are willing to sign an informed consent form, indicating that they are aware of the investigational nature of this study that is in keeping with the policies of the institution; (4) willing to return to the study site for their study visits. The reason for our inclusion criteria is that women experienced several unsuccessful OAs or ETs may easily accept randomization to this study, and for whom adding TEAS or EA may significantly improve their clinical outcomes.
Who cannot join
- major medical illnesses (like stage III heart disease, severe hypertension, uncontrolled diabetes mellitus, HIV positivity, severe bleeding dyscrasias, etc.) possibly precluding IVF or pregnancy; (2) FSH more than 20 IU/L; (3) receiving donor eggs; (4) cutaneous lesion of certain acupoint area; (5) having been previously participated in this study or having undertaken acupuncture (in whatever modality) treatment for infertility.
Trial locations and contacts
1 site in 1 country.
China1 site
IVF center of Tongji Hospital,Tongji medical college,HUST
Wuhan, Hubei, 430030
Cui Hong Zheng, Doctor
About this study
The objective of this study is to investigate the effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization.
- Being tested
- transcutaneous electrical acupoint stimulation (TEAS);EA
- Keywords
- In-vitro Fertilization, transcutaneous electrical acupoint stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulation (TEAS);EADevice
TEAS group (conventional IVF + TEAS), electro-acupuncture (EA) group (conventional IVF + electro-Acu.), and control group (only conventional IVF) Parameter of TEAS or EA: frequency of 2/100 Hz；moderate electrical current. Treatments start from the day 3 of menstruation，once every two days, 30 min for each for two continuous weeks.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| TEAS | Experimental | Not described Receives: Device: transcutaneous electrical acupoint stimulation (TEAS);EA |
| EA:electro-acupuncture | Experimental | Not described Receives: Device: transcutaneous electrical acupoint stimulation (TEAS);EA |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate (CPR)
Measured: 1 year
Secondary outcomes (1)
Live birth rate (LBR)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMay 2014
- Primary completionApr 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supervision of Pregnancy Resulting From In-vitro FertilizationStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan General Hospital of Guangzhou Military Command
- Responsible party
- Principal investigator, Cui Hong Zheng, Huazhong University of Science and Technology
- Investigators
- Cui Hong Zheng, Doctor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608048
- Sponsor's protocol ID
- CZheng2012QN180
- Status last verified
- Nov 2012
- First submitted
- 24 May 2012
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zheng CH, Zhang J, Wu J, Zhang MM. The effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization: a study protocol for a randomized controlled trial. Trials. 2014 May 9;15:162. doi: 10.1186/1745-6215-15-162.
PubMed 24886647
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint Stimulation to Improve Pregnancy Rates for Women Undergoing in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01608048
- Acronym / sponsor ID
- CZheng2012QN180
- Keywords
- In-vitro Fertilization, transcutaneous electrical acupoint stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan General Hospital of Guangzhou Military Command
- Study start
- May 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 30 May 2012 (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 objective of this study is to investigate the effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| TEAS | Experimental | Device: transcutaneous electrical acupoint stimulation (TEAS);EA |
| EA:electro-acupuncture | Experimental | Device: transcutaneous electrical acupoint stimulation (TEAS);EA |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertile women < 40 years of age, undergoing a fresh IVF or intracytoplasmic sperm injection (ICSI) cycle; (2) be an appropriate candidate with the potential for a lower success rate which defined as two or more previous unsuccessful ETs (fresh or frozen); (3) are willing to sign an informed consent form, indicating that they are aware of the investigational nature of this study that is in keeping with the policies of the institution; (4) willing to return to the study site for their study visits. The reason for our inclusion criteria is that women experienced several unsuccessful OAs or ETs may easily accept randomization to this study, and for whom adding TEAS or EA may significantly improve their clinical outcomes.
Key exclusion criteria (1 listed)
- major medical illnesses (like stage III heart disease, severe hypertension, uncontrolled diabetes mellitus, HIV positivity, severe bleeding dyscrasias, etc.) possibly precluding IVF or pregnancy; (2) FSH more than 20 IU/L; (3) receiving donor eggs; (4) cutaneous lesion of certain acupoint area; (5) having been previously participated in this study or having undertaken acupuncture (in whatever modality) treatment for infertility.
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 |
|---|---|---|
| transcutaneous electrical acupoint stimulation (TEAS);EATEAS group (conventional IVF + TEAS), electro-acupuncture (EA) group (conventional IVF + electro-Acu.), and control group (only conventional IVF) Parameter of TEAS or EA: frequency of 2/100 Hz；moderate electrical current. Treatments start from the day 3 of menstruation，once every two days, 30 min for each for two continuous weeks. | Device | EA:electro-acupuncture, TEAS |
Primary outcome
clinical pregnancy rate (CPR)
Time frame: 1 year
1 secondary outcome
Live birth rate (LBR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
- Derived from this study: PubMed 24886647Zheng CH, Zhang J, Wu J, Zhang MM. The effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization: a study protocol for a randomized controlled trial. Trials. 2014 May 9;15:162. doi: 10.1186/1745-6215-15-162.
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.
Cui Hong Zheng, Doctor principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation (TEAS);EA in people with Supervision of Pregnancy Resulting From In-vitro Fertilization, run by Huazhong University of Science and Technology 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Apr 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cui Hong Zheng, Doctor (86-27-83663275, 635342693@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (CPR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608048, which also lists 1 linked publication.
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 Apr 2014.