Repeated Implantation FailureNCT04533295
Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF
A study testing acupuncture and IVF in people with Repeated Implantation Failure, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into three groups: acupuncture group (Acu.+IVF），sham acupuncture group（Sham Acu. +IVF），and the control group (only IVF). Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Repeated Implantation Failure
- What is being tested?
- acupuncture and IVF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 771 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2020to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Married women aged 25-40;
- Repeated implantation failure for unknown reasons (experienced 2 or more embryo transfers of good-quality embryos without achieving clinical pregnancy);
- Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (≥3BB);
- Estrogen and progesterone replacement therapy (HRT), endometrial thickness ≥7mm on the day of endometrial transformation.
Who cannot join
- Patients who met any of the following conditions were not included.
- Those who prepare for PGD;
- Recipients of egg donors;
- Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism);
- patients with implantation failure due to known embryonic factors;
- Uterine lesions that may affect implantation (including uterine malformation, >4cm intramural fibroids，submucosal fibroids, adenomyosis, uterine tuberculosis, intrauterine adhesions, etc.
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- Repeated spontaneous abortion (2 or more fetal loss before 28 weeks of gestation);
- Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months;
- Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;
- Hydrosalpinx untreated;
- BMI less than 18 or higher than 25kg/m2;
- People with previous history of needle sickness;
- Those who have previously participated in this study or received acupuncture treatment in the past 3 months.
- Any situation that researchers consider inappropriate for participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital,Tongji medical college,HUST
Wuhan, Hubei, 430030
Cuihong Zheng, professor
Minming Zhang, professor
About this study
Official title: Effect of Acupuncture on IVF Pregnancy Outcomes for Women With Recurrent Implantation Failure: a Multi-center Randomized Controlled Clinical Trial
The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into three groups: acupuncture group (Acu.+IVF），sham acupuncture group（Sham Acu. +IVF），and the control group (only IVF).
- Conditions
- Repeated Implantation Failure
- Being tested
- acupuncture and IVF, sham acupuncture and IVF, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture and IVFDevice
Acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer.
sham acupuncture and IVFDevice
Sham acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer.
control groupOther
no acupuncture, only IVF
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Acupuncture + IVF. Receives: Device: acupuncture and IVF |
| Sham acupuncture group | Sham comparator | Sham acupuncture +IVF. We formulate and follow standardised step-by-step instructions and operations to use the same rituals in the acupuncture and sham acupuncture groups as far as possible. Receives: Device: sham acupuncture and IVF |
| control group | Other | only IVF Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR
Clinical pregnancy rate
Measured: 1 year
Secondary outcomes (5)
OPR
ongoing pregnancy rate
Measured: 1 year
LBR
Live birth rate
Measured: 1 year
Biochemical indexes
Biochemical indexes
Measured: before and after acupuncture treatment
Questionnaire score
Questionnaire score
Measured: before and after acupuncture treatment
β-HCG positive rate
level of serum β-HCG positive rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start2 Nov 2020
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated Implantation FailureStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 771 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Hong Zheng, Huazhong University of Science and Technology
- Investigators
- Minming Zhang, professor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533295
- Sponsor's protocol ID
- 2019CR110
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on IVF Pregnancy Outcomes for Women With Recurrent Implantation Failure: a Multi-center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04533295
- Acronym / sponsor ID
- 2019CR110
- Conditions
- Repeated Implantation Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 771 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 31 Aug 2020 (actual)
- 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 randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into three groups: acupuncture group (Acu.+IVF），sham acupuncture group（Sham Acu. +IVF），and the control group (only IVF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: acupuncture and IVFAcupuncture + IVF. |
| Sham acupuncture group | Sham comparator | Device: sham acupuncture and IVFSham acupuncture +IVF. We formulate and follow standardised step-by-step instructions and operations to use the same rituals in the acupuncture and sham acupuncture groups as far as possible. |
| control group | Other | Other: control grouponly IVF |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Married women aged 25-40;
- Repeated implantation failure for unknown reasons (experienced 2 or more embryo transfers of good-quality embryos without achieving clinical pregnancy);
- Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (≥3BB);
- Estrogen and progesterone replacement therapy (HRT), endometrial thickness ≥7mm on the day of endometrial transformation.
Key exclusion criteria (14 listed)
- Patients who met any of the following conditions were not included.
- Those who prepare for PGD;
- Recipients of egg donors;
- Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism);
- patients with implantation failure due to known embryonic factors;
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 and IVFAcupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer. | Device | Acupuncture group |
| sham acupuncture and IVFSham acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer. | Device | Sham acupuncture group |
| control groupno acupuncture, only IVF | Other | control group |
Primary outcome
CPR
Time frame: 1 year
Clinical pregnancy rate
5 secondary outcomes
OPR
Time frame: 1 year
LBR
Time frame: 1 year
Biochemical indexes
Time frame: before and after acupuncture treatment
Questionnaire score
Time frame: before and after acupuncture treatment
β-HCG positive rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- 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.
Minming Zhang, professor 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 acupuncture and IVF in people with Repeated Implantation Failure, 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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cuihong Zheng, professor (86-27-83663275, chzheng@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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?
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 10 Mar 2026.