InfertilityNCT01481090
Electro-acupuncture and Assisted Reproductive Technology
A study testing Acupuncture, Electro-Acupuncture in people with Infertility, run by National University of Health Sciences at 2 sites in United States.
Trial summary
One of the most widely used procedures in reproductive medicine technologies is In Vitro Fertilization (IVF). During the IVF procedure, there are sometimes unused embryos that are frozen to be used at later times. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Acupuncture, Electro-Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Mar 2012
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing medicated frozen embryo transfer uterine preparation
- Ages between 21-45 years old
- Must be fluent in English
- Must be willing to receive four electro-acupuncture treatments
- Must be willing to provide access to medical records from the fertility clinic
Who cannot join
- Males
- Subjects involved with fresh IVF cycle
- Subjects with pace maker
- Subjects with history of seizure disorders
- All others who do not meet the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tiffani Kim Institute
Chicago, Illinois, 60654
National University of Health Sciences
Lombard, Illinois, 60148
About this study
Official title: Electro-acupuncture and Assisted Reproductive Technology: Impact of EA on Endometrium During Medicated Frozen Embryo Transfer Uterine Preparation
One of the most widely used procedures in reproductive medicine technologies is In Vitro Fertilization (IVF). During the IVF procedure, there are sometimes unused embryos that are frozen to be used at later times. If these embryos are thawed and transferred back to the mother, proper development of the uterine lining plays an important role in outcome of pregnancy. Electro-acupuncture (EA), a technique where electrical current is applied to the needle to stimulate an acupoint, has been shown to increase uterine blood flow, increasing the likelihood of developing a more ideal endometrial lining. This randomized study aims to evaluate the impact of EA on endometrium undergoing medicated frozen embryo transfer cycle preparation. The treatment group will receive four acupuncture treatments during the medicated uterine preparation. Endometrial thickness will be compared to a group that does not receive acupuncture.
Read the detailed description
All the subjects in the study will be randomized and their participation is completely voluntary. Patients recruited to join the study will not receive any monetary compensation for participation.
This research will include 100 female subjects, ages 21-45, undergoing medicated frozen embryo transfer (mFET). The subjects will be randomized into treatment and the non-treatment groups. The non-treatment group will undergo the medicated uterine preparation for FET according to the fertility clinic's protocol.
Subjects in the treatment group will receive four electro-acupuncture (EA) treatments in addition to the mFET protocol, starting after the 1st Ultrasound measurement which constitutes as a baseline, until the start of the progesterone administration. Endometrial thickness will be measured using ultrasound and estrogen (E2) levels will be measured by blood samples as a standard measure to assess the time of P4 (progesterone) supplementation. This step will be done by the participant's fertility clinic according to the clinic's protocol.
Acupuncture points of LI-4, LV-3, SP-6, Zi Gong, CV-3, CV-4, ST-36 will be needled. Electro-stimulation will be applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4 at low frequency. The needle retention with electro-stimulation will last for 25 minutes. After the 25 minutes, the needles and the electro-stimulation will be removed and the patients will be dismissed.
Ultrasound results measuring endometrium will be obtained from the subject's fertility clinic. US and bloodwork will be performed at baseline, and before the progesterone administration according to the fertility clinic. This US measurement and bloodwork results will be used for statistical analysis to compare endometrial lining of the two groups. The final discussion will be presented according to the findings.
- Conditions
- Infertility
- Being tested
- Acupuncture, Electro-Acupuncture
- Keywords
- Infertility, acupuncture, frozen embryos, endometrium, TCM
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture, Electro-AcupunctureProcedure or surgery
Participants will receive 4 Electro-acupuncture stimulation applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4acupuncture treatments during hormone treatment.
| Study group | Role | What they receive |
|---|---|---|
| Electro-Acupuncture | Active comparator | Group will receive 4 acupuncture treatments over 14 days during hormone treatment Receives: Procedure: Acupuncture, Electro-Acupuncture |
| Control | No intervention | Group will not receive acupuncture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endometrium thickness during hormone treatment
As part of the preparation for embryo transfer, patients undergo ultrasound during hormone treatment to assess endometrium thickness. Research participants will agree to release ultrasound results to the research personnel to determine whether acupuncture treatments affect endometrium thickness compared to no acupuncture treatment.
Measured: Baseline, day 8 and day 15 of hormone treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: IRB violations
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.
- 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Y Cai, Ph.D, Principal investigator, National University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481090
- Sponsor's protocol ID
- NUHS H1007
- Status last verified
- Apr 2015
- First submitted
- 22 Nov 2011
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-acupuncture and Assisted Reproductive Technology: Impact of EA on Endometrium During Medicated Frozen Embryo Transfer Uterine Preparation
- ClinicalTrials.gov ID
- NCT01481090
- Acronym / sponsor ID
- NUHS H1007
- Conditions
- Infertility
- Keywords
- Infertility, acupuncture, frozen embryos, endometrium, TCM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB violations
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National University of Health SciencesUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Nov 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.
One of the most widely used procedures in reproductive medicine technologies is In Vitro Fertilization (IVF). During the IVF procedure, there are sometimes unused embryos that are frozen to be used at later times. If these embryos are thawed and transferred back to the mother, proper development of the uterine lining plays an important role in outcome of pregnancy. Electro-acupuncture (EA), a technique where electrical current is applied to the needle to stimulate an acupoint, has been shown to increase uterine blood flow, increasing the likelihood of developing a more ideal endometrial lining. This randomized study aims to evaluate the impact of EA on endometrium undergoing medicated frozen embryo transfer cycle preparation. The treatment group will receive four acupuncture treatments during the medicated uterine preparation. Endometrial thickness will be compared to a group that does not receive acupuncture.
Detailed description
All the subjects in the study will be randomized and their participation is completely voluntary. Patients recruited to join the study will not receive any monetary compensation for participation.
This research will include 100 female subjects, ages 21-45, undergoing medicated frozen embryo transfer (mFET). The subjects will be randomized into treatment and the non-treatment groups. The non-treatment group will undergo the medicated uterine preparation for FET according to the fertility clinic's protocol.
Subjects in the treatment group will receive four electro-acupuncture (EA) treatments in addition to the mFET protocol, starting after the 1st Ultrasound measurement which constitutes as a baseline, until the start of the progesterone administration. Endometrial thickness will be measured using ultrasound and estrogen (E2) levels will be measured by blood samples as a standard measure to assess the time of P4 (progesterone) supplementation. This step will be done by the participant's fertility clinic according to the clinic's protocol.
Acupuncture points of LI-4, LV-3, SP-6, Zi Gong, CV-3, CV-4, ST-36 will be needled. Electro-stimulation will be applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4 at low frequency. The needle retention with electro-stimulation will last for 25 minutes. After the 25 minutes, the needles and the electro-stimulation will be removed and the patients will be dismissed.
Ultrasound results measuring endometrium will be obtained from the subject's fertility clinic. US and bloodwork will be performed at baseline, and before the progesterone administration according to the fertility clinic. This US measurement and bloodwork results will be used for statistical analysis to compare endometrial lining of the two groups. The final discussion will be presented according to the findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electro-Acupuncture | Active comparator | Procedure: Acupuncture, Electro-AcupunctureGroup will receive 4 acupuncture treatments over 14 days during hormone treatment |
| Control | No intervention | –Group will not receive acupuncture. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women undergoing medicated frozen embryo transfer uterine preparation
- Ages between 21-45 years old
- Must be fluent in English
- Must be willing to receive four electro-acupuncture treatments
- Must be willing to provide access to medical records from the fertility clinic
Key exclusion criteria (5 listed)
- Males
- Subjects involved with fresh IVF cycle
- Subjects with pace maker
- Subjects with history of seizure disorders
- All others who do not meet the inclusion criteria
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 |
|---|---|---|
| Acupuncture, Electro-AcupunctureParticipants will receive 4 Electro-acupuncture stimulation applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4acupuncture treatments during hormone treatment. | Procedure or surgery | Electro-Acupuncture |
Primary outcome
Change in endometrium thickness during hormone treatment
Time frame: Baseline, day 8 and day 15 of hormone treatment
As part of the preparation for embryo transfer, patients undergo ultrasound during hormone treatment to assess endometrium thickness. Research participants will agree to release ultrasound results to the research personnel to determine whether acupuncture treatments affect endometrium thickness compared to no acupuncture treatment.
Results and safety
The study was stopped early (reason given: IRB violations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
Hui Y Cai, Ph.D principal investigator
National University of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, Electro-Acupuncture in people with Infertility, run by National University of Health Sciences at 2 sites in United States.
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 5 inclusion and 5 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: IRB violations). 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?
Change in endometrium thickness during hormone treatment (time frame: Baseline, day 8 and day 15 of hormone treatment). 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 15 Apr 2015; AzTrials last refreshed its copy on 29 Oct 2026.