Unexplained InfertilityAURISNCT02624076
Acupuncture for Unexplained Subfertiliy
A study testing Acupuncture and expectant management in people with Unexplained Infertility, run by Heilongjiang University of Chinese Medicine at 16 sites in China.
Trial summary
Infertility affects one in six couples. In a quarter of them, routine tests of semen quality, ovulation or tubal patency fail to reveal any abnormalities and the cause of infertility is unexplained. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- Acupuncture and expectant management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,423 participants
- Where
- 16 sitesChina
- Study dates
- Dec 2015to Jan 2018
- 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
- Women aged 18-40 years
- Bilateral patent tubes demonstrated by hysterosalpingogram, hysterosalpingo-contrast sonography or laparoscopy
- Regular menses 21 to 35 days Normal semen parameters :Total motile sperm count ≥10 million. (World Health Organization criteria, 2010)
Who cannot join
- Unwillingness to accept either of the two interventions
- Contra-indications to acupuncture: pacemaker use or bleeding disorder
- Received acupuncture before 2 months for other diseases which are not related to unexplained infertility.
- Previously received acupuncture for unexplained infertility
- Use of hormonal or other medication (including Chinese Herbal prescriptions) which may affect the outcome in the past 2 months.
- Patients who anticipate taking longer than a one month break from treatment during the trial (i.e. 4 months from randomization).
Trial locations and contacts
16 sites in 1 country.
Hui Chang, MD contact
16 sites in 1 country
China16 sites
First Affiliated Hospital of Hunan University of Chinese
Changsha, Hunan
The Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163000
Daqing Longnan hospital
Daqing, Heilongjiang
Daqing Oilfield General Hospital
Daqing, Heilongjiang
Guangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong
Hangzhou Chinese Medicine Hospital
Hangzhou, 310000
Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Harbin, Heilongjiang, 150040
Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040
Xiaoke Wu, MD.PhD., 86-451-8213 0094, xiaokewu2002@vip.sina.com
Xiaoke Wu, MD.PhD.
Jiangxi University of Chinese Medicine Affiliated Hospital
Nanchang, Jiangxi, 330000
First Hospital, Jiangxi college of Chinese Medicine
Nanchang, Jiangxi
Shanxi Chinese Medicine Hospital
Shangxi, Shanxi, 030012
Shanxi Hospital of Chinese Medicine
Taiyuan, Shanxi
Tianjin Tanggu Maternity and Child Care Center
Tianjin, Tianjin Municipality, 300451
First Affiliated Hospital of Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality
Wenzhou Chinese Medicine Hospital
Wenzhou, Zhejiang, 325000
Maternal and Child Health Hospital of Xuzhou
Xuzhou, Jiangsu
About this study
Official title: A Randomized Controlled Trial of Acupuncture Versus Expectant Management in Women With Unexplained Infertility
Infertility affects one in six couples. In a quarter of them, routine tests of semen quality, ovulation or tubal patency fail to reveal any abnormalities and the cause of infertility is unexplained. Acupuncture is being increasingly used by couples with all types of infertility and initial trials have suggested that it could be potentially beneficial in some cases. A number of systematic reviews of acupuncture in IVF have shown conflicting results, but there is no evidence to inform best practice in unexplained infertility. In addition, as an intervention, acupuncture is not cost neutral as it involves multiple visits for treatment sessions delivered by a skilled practitioner. Thus, while acupuncture could have the potential to increase live birth rates in women with unexplained infertility, the clinical and cost effectiveness of acupuncture needs to be confirmed in the context of a large randomized controlled trial.
- Conditions
- Unexplained Infertility
- Being tested
- Acupuncture, expectant management
- Keywords
- unexplained infertility, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
semi-fixed protocol will be used including four local core points; conception vessel (CV) 3, CV 6, and stomach (ST) 29 bilaterally and four in the leg/feet; spleen (SP) 6, and SP 9 bilaterally. The core points CV 3, CV 6, ST 29, SP 6, and SP 9 are thereafter connected to electrical stimulator (Hwoto, China) and stimulated with low-frequency, 2Hz, 0.5 ms
expectant managementOther
one initial counselling session, an information leaflet on timed intercourse, access to a telephone helpline for queries and ad hoc support on demand from the fertility clinic over a period of 4 months post randomization.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture plus expectant management | Experimental | Not described Receives: Other: Acupuncture; Other: expectant management |
| expectant management | Active comparator | Not described Receives: Other: expectant management |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
Measured: Up to 4 months
Secondary outcomes (5)
pregnancy rate
Measured: Up to 14 months
Miscarriage rate
Measured: Up to 14 months
Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.
Measured: Up to 14 months
quality of life
Measured: Up to 14 months
Side effect
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,423 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoke Wu, First Affiliated Hospital of Heilongjiang Chinese Medicine University
- Investigators
- Xiaoke Wu, MD.PhD., Study chair, The First Affliated Hospital,Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624076
- Sponsor's protocol ID
- AURIS2015
- Acronym
- AURIS
- Status last verified
- Dec 2015
- First submitted
- 24 Nov 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Acupuncture Versus Expectant Management in Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT02624076
- Acronym / sponsor ID
- AURIS / AURIS2015
- Conditions
- Unexplained Infertility
- Keywords
- unexplained infertility, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,423 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2018 (estimated)
- First posted
- 8 Dec 2015 (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.
Infertility affects one in six couples. In a quarter of them, routine tests of semen quality, ovulation or tubal patency fail to reveal any abnormalities and the cause of infertility is unexplained. Acupuncture is being increasingly used by couples with all types of infertility and initial trials have suggested that it could be potentially beneficial in some cases. A number of systematic reviews of acupuncture in IVF have shown conflicting results, but there is no evidence to inform best practice in unexplained infertility. In addition, as an intervention, acupuncture is not cost neutral as it involves multiple visits for treatment sessions delivered by a skilled practitioner. Thus, while acupuncture could have the potential to increase live birth rates in women with unexplained infertility, the clinical and cost effectiveness of acupuncture needs to be confirmed in the context of a large randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture plus expectant management | Experimental | Other: Acupuncture, Other: expectant management |
| expectant management | Active comparator | Other: expectant management |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-40 years
- Bilateral patent tubes demonstrated by hysterosalpingogram, hysterosalpingo-contrast sonography or laparoscopy
- Regular menses 21 to 35 days Normal semen parameters :Total motile sperm count ≥10 million. (World Health Organization criteria, 2010)
Key exclusion criteria (6 listed)
- Unwillingness to accept either of the two interventions
- Contra-indications to acupuncture: pacemaker use or bleeding disorder
- Received acupuncture before 2 months for other diseases which are not related to unexplained infertility.
- Previously received acupuncture for unexplained infertility
- Use of hormonal or other medication (including Chinese Herbal prescriptions) which may affect the outcome in the past 2 months.
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 |
|---|---|---|
| Acupuncturesemi-fixed protocol will be used including four local core points; conception vessel (CV) 3, CV 6, and stomach (ST) 29 bilaterally and four in the leg/feet; spleen (SP) 6, and SP 9 bilaterally. The core points CV 3, CV 6, ST 29, SP 6, and SP 9 are thereafter connected to electrical stimulator (Hwoto, China) and stimulated with low-frequency, 2Hz, 0.5 ms | Other | Acupuncture plus expectant management |
| expectant managementone initial counselling session, an information leaflet on timed intercourse, access to a telephone helpline for queries and ad hoc support on demand from the fertility clinic over a period of 4 months post randomization. | Other | Acupuncture plus expectant management, expectant management |
Primary outcome
live birth rate
Time frame: Up to 4 months
5 secondary outcomes
pregnancy rate
Time frame: Up to 14 months
Miscarriage rate
Time frame: Up to 14 months
Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.
Time frame: Up to 14 months
quality of life
Time frame: Up to 14 months
Side effect
Time frame: Up to 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 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 Chang, MD contact
Xiaoke Wu, MD.PhD. study chair
The First Affliated Hospital,Heilongjiang University of Chinese Medicine
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and expectant management in people with Unexplained Infertility, run by Heilongjiang University of Chinese Medicine at 16 sites 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 3 inclusion and 6 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 Hui Chang, MD (changhui1903@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: Up to 4 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 21 Dec 2015.