PCOSNCT01778621
Effect of Acupuncture on Anti Mullerian Hormone and Assisted Reproduction Outcome in PCOS Patients Undergoing IVF
A study testing Acupuncture(Hwato®) in people with PCOS, run by Amina Altutunji at 1 site in China.
Trial summary
Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims to compare assisted reproduction outcome between two groups of PCOS patients underwent IVF, one group received acupuncture and other group without acupuncture. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Acupuncture(Hwato®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to May 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS patients with patent one or two fallopian tubes, normal uterine cavity and partners with normal semen parameters.
- infertility
- 20-40 years
- IVF treatment -
Who cannot join
- patients with disorders that have the similar clinical presentation
- closed both tubes
- abnormal semen parameters
- intracytoplasmic sperm injection (ICSI)
Trial locations and contacts
1 site in 1 country.
China1 site
Assisted Reproduction Center, Department of Obstetrics and Gynecology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: Acupuncture Treatment Versus Non-acupuncture During IVF
Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims to compare assisted reproduction outcome between two groups of PCOS patients underwent IVF, one group received acupuncture and other group without acupuncture.
Read the detailed description
Follicular phase acupuncture applied for PCOS patients underwent IVF to evaluate the effect of acupuncture on anti-mullerian hormone (AMH) and the effect on assisted reproduction outcome. It applied at certain acupoints according to the principles of traditional Chinese medicine.
- Conditions
- PCOS
- Being tested
- Acupuncture(Hwato®)
- Keywords
- Acupuncture, AMH, PCOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture(Hwato®)Device
acupuncture using 4cm long disposable stainless steel hair-thin needles manufactured by Suzhou medical appliance factory (China).
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture (Hwato®) | Experimental | 30-40 minutes acupuncture at certain acupoints that chosen according to traditional Chinese medicine and included LIV3,SP6,SP8,ST36,SP10,ST29,LI14,Ren 04;starting at follicular phase of the cycle till 2 days before oocyte picked up. Receives: Device: Acupuncture(Hwato®) |
| No acupuncture | No intervention | No intervention was done for this group of patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate.
Increase in pregnancy rate
Measured: 13 months
Secondary outcomes (1)
Ongoing pregnancy rate
Increase in ongoing pregnancy rate
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amina Altutunji
- Sponsor type
- University, hospital or other
- Collaborators
- Huazhong University of Science and Technology
- Responsible party
- Sponsor-investigator, Amina Altutunji, Huazhong University of Science and Technology
- Investigators
- Ying Gao, Ph.D., M.D., Study director, Assisted Reproduction Center, Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778621
- Sponsor's protocol ID
- MINA-1978
- Status last verified
- Jul 2019
- First submitted
- 23 Jan 2013
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment Versus Non-acupuncture During IVF
- ClinicalTrials.gov ID
- NCT01778621
- Acronym / sponsor ID
- MINA-1978
- Conditions
- PCOS
- Keywords
- Acupuncture, AMH, PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Amina AltutunjiUniversity, hospital or other
- Collaborators
- Huazhong University of Science and Technology
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Jan 2013 (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.
Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims to compare assisted reproduction outcome between two groups of PCOS patients underwent IVF, one group received acupuncture and other group without acupuncture.
Detailed description
Follicular phase acupuncture applied for PCOS patients underwent IVF to evaluate the effect of acupuncture on anti-mullerian hormone (AMH) and the effect on assisted reproduction outcome. It applied at certain acupoints according to the principles of traditional Chinese medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture (Hwato®) | Experimental | Device: Acupuncture(Hwato®)30-40 minutes acupuncture at certain acupoints that chosen according to traditional Chinese medicine and included LIV3,SP6,SP8,ST36,SP10,ST29,LI14,Ren 04;starting at follicular phase of the cycle till 2 days before oocyte picked up. |
| No acupuncture | No intervention | –No intervention was done for this group of patients. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PCOS patients with patent one or two fallopian tubes, normal uterine cavity and partners with normal semen parameters.
- infertility
- 20-40 years
- IVF treatment -
Key exclusion criteria (4 listed)
- patients with disorders that have the similar clinical presentation
- closed both tubes
- abnormal semen parameters
- intracytoplasmic sperm injection (ICSI)
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(Hwato®)acupuncture using 4cm long disposable stainless steel hair-thin needles manufactured by Suzhou medical appliance factory (China). | Device | Acupuncture (Hwato®) |
Primary outcome
Clinical pregnancy rate.
Time frame: 13 months
Increase in pregnancy rate
1 secondary outcome
Ongoing pregnancy rate
Time frame: 15 months
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 23 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Ying Gao, Ph.D., M.D. study director
Assisted Reproduction Center, Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture(Hwato®) in people with PCOS, run by Amina Altutunji 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 4 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 23 Jul 2019. 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?
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?
Clinical pregnancy rate. (time frame: 13 months). 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 23 Jul 2019.