In Vitro FertilizationIVFActNCT04407871
Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization (IVFAct)
A study testing Acupuncture and Chinese Herbal Medicine in people with In Vitro Fertilization, run by Heilongjiang University of Chinese Medicine at 12 sites in China.
Trial summary
The most successful treatment for infertility is in vitro fertilization (IVF), but less than 10% of infertile couples undergo IVF because of the high cost and relatively low success rate. Many patients have tried complementary and alternative medical treatments as an adjuvant therapy to improve their IVF success. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- Acupuncture and Chinese Herbal Medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,728 participants
- Where
- 12 sitesChina
- Study dates
- 1 Nov 2021to 31 Dec 2022
- 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
- Women ≥20 to ≤40 years of age
- Indications for IVF
- Duration of infertility >1 year
- Undergoing IVF with an intention of fresh ET on day 3 or 5.
Who cannot join
- Women with an intention to replace frozen embryos only.
- Preimplantation genetic testing
- History of recurrent miscarriages defined as having three consecutive miscarriages.
- Having acupuncture or CHM for infertility within 3 months prior the IVF
- Women with abnormal liver or renal function tests
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Dalian Municipal Women and Children's Medical Center
Dalian, Liaoning
Xiaoguang Shao, 13804086511, shaoxiaoguang03@sohu.com
Xiaoguang Shao
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Yunxia Cao, 13605605972
Yunxia Cao
The Chinese University of Hong Kong
Hong Kong
Ronald Wang, ccwang@cuhk.edu.hk
Ronald Wang
Huaian Maternal and Child Health Hospital
Huai'an, Jiangsu
Huiying Xue
Huiying Xue
The First Hospital of Lanzhou University
Lanzhou, Gansu
Xuehong Zhang, 13893215266
Xuehong Zhang
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi
Qiongfang Wu
Qiongfang Wu
The First Affiliated Hospital of Nanjing University Medical School (Nanjing Drum Tower Hospital)
Nanjing, Jiangsu
Haixiang Sun, 13851622008
Haixiang Sun
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Jichun Tan, 18940251868
Jichun Tan
Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei
Hanwang Zhang, Hwzhang605@126.com
Hanwang Zhang
Xibei Women and Children's Hospital
Xi’an, Shanxi
Juanzi Shi
Juanzi Shi
Xuzhou Central Hospital
Xuzhou, Jiangsu
Yijuan Cao, 18952171922
Yijuan Cao
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yingpu Sun, 13503841888
Yingpu Sun
About this study
Official title: Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization - A Randomized Controlled Trial (IVFAct)
The most successful treatment for infertility is in vitro fertilization (IVF), but less than 10% of infertile couples undergo IVF because of the high cost and relatively low success rate. Many patients have tried complementary and alternative medical treatments as an adjuvant therapy to improve their IVF success. Acupuncture given 2-4 times around the day of embryo transfer has not been shown to improve the IVF live birth rate. Chinese Herbal Medicine (CHM) may improve the IVF pregnancy rates, but the evidence so far is inconclusive because of high risks of bias in these studies.
The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.
Read the detailed description
The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.
- Conditions
- In Vitro Fertilization
- Being tested
- Acupuncture and Chinese Herbal Medicine
- Keywords
- In Vitro Fertilization, Chinese Herbal Medicine, Acupuncture, Live Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and Chinese Herbal MedicineOther
- acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM by an interactive online computer program in a central office. Using a 1:1:1:1 treatment ratio, there will be 682 women assigned to each treatment group.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture and CHM | Experimental | Women will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after embryo transfer (ET). They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. Receives: Other: Acupuncture and Chinese Herbal Medicine |
| acupuncture and placebo CHM | Placebo comparator | Women will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. Receives: Other: Acupuncture and Chinese Herbal Medicine |
| control acupuncture and CHM | Placebo comparator | Women will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. Receives: Other: Acupuncture and Chinese Herbal Medicine |
| control acupuncture and placebo CHM | Placebo comparator | Women will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. Receives: Other: Acupuncture and Chinese Herbal Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Live birth defined as a delivery ≥20weeks gestation per transfer in the stimulated IVF cycles or in the first frozen-thawed embryo transfer cycle in those with elective freezing of all embryos
Measured: ≥20 weeks of gestation
Secondary outcomes (14)
Embryo quality: embryo scoring standard
Embryo quality is judged by embryo scoring standard
Measured: On the third day after egg retrieval and before embryo transfer
Miscarriage rate
Cumulative miscarriage rate
Measured: ≤42 weeks of gestation
Implantation rate
Cumulative implantation rate
Measured: 2 weeks after embryo transfer
Positive serum human chorionic gonadotropin (hCG) level
Positive serum hCG level 2 weeks after embryo transfer
Measured: 2 weeks after embryo transfer
Ongoing pregnancy rate
Cumulative ongoing pregnancy rate
Measured: ≥8 weeks
Multiple pregnancy rate
Cumulative multiple pregnancy rate
Measured: ≥2 weeks after embryo transfer
Ectopic pregnancy rate
Cumulative ectopic pregnancy rate
Measured: ≥2 weeks after embryo transfer
Cumulative live birth rate
Cumulative live birth rate
Measured: within 6 months after randomization
Changes in markers of stress, anxiety
To elucidate the anxiety level as measured with serum cortisol concentration and Stait-Trait Anxiety Inventory (STAI)
Measured: ≤8 weeks of gestation
Health related quality of life(HRQoL)
To determine women's health related quality of life (HRQoL) by short-form 36 (SF36)
Measured: ≤8 weeks of gestation
Patient acceptability: acupuncture trust score
Patient acceptability of acupuncture to be measured by acupuncture trust score
Measured: On the day of embryo transfer
Side effects
Side effects
Measured: ≤ 8 weeks of gestation
Congenital abnormalities
Judging by prenatal ultrasound and postnatal physical examination
Measured: at 6 weeks postpartum
Pregnancy complications
Complications of Pregnancy
Measured: ≤42 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Nov 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoke Wu, Heilongjiang University of Chinese Medicine
- Investigators
- Xiaoke Wu, Ph.D, Study chair, First Affiliated Hospital in Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407871
- Sponsor's protocol ID
- IVFAct
- Acronym
- IVFAct
- Status last verified
- Sep 2021
- First submitted
- 18 May 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subject's privacy is protected undoubtedly at the time of the informed consent signing
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization - A Randomized Controlled Trial (IVFAct)
- ClinicalTrials.gov ID
- NCT04407871
- Acronym / sponsor ID
- IVFAct / IVFAct
- Conditions
- In Vitro Fertilization
- Keywords
- In Vitro Fertilization, Chinese Herbal Medicine, Acupuncture, Live Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,728 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 May 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 most successful treatment for infertility is in vitro fertilization (IVF), but less than 10% of infertile couples undergo IVF because of the high cost and relatively low success rate. Many patients have tried complementary and alternative medical treatments as an adjuvant therapy to improve their IVF success. Acupuncture given 2-4 times around the day of embryo transfer has not been shown to improve the IVF live birth rate. Chinese Herbal Medicine (CHM) may improve the IVF pregnancy rates, but the evidence so far is inconclusive because of high risks of bias in these studies.
The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.
Detailed description
The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| acupuncture and CHM | Experimental | Other: Acupuncture and Chinese Herbal MedicineWomen will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after embryo transfer (ET). They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. |
| acupuncture and placebo CHM | Placebo comparator | Other: Acupuncture and Chinese Herbal MedicineWomen will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. |
| control acupuncture and CHM | Placebo comparator | Other: Acupuncture and Chinese Herbal MedicineWomen will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. |
| control acupuncture and placebo CHM | Placebo comparator | Other: Acupuncture and Chinese Herbal MedicineWomen will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women ≥20 to ≤40 years of age
- Indications for IVF
- Duration of infertility >1 year
- Undergoing IVF with an intention of fresh ET on day 3 or 5.
Key exclusion criteria (5 listed)
- Women with an intention to replace frozen embryos only.
- Preimplantation genetic testing
- History of recurrent miscarriages defined as having three consecutive miscarriages.
- Having acupuncture or CHM for infertility within 3 months prior the IVF
- Women with abnormal liver or renal function tests
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 Chinese Herbal Medicine1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM by an interactive online computer program in a central office. Using a 1:1:1:1 treatment ratio, there will be 682 women assigned to each treatment group. | Other | acupuncture and CHM, acupuncture and placebo CHM, control acupuncture and CHM, control acupuncture and placebo CHM |
Primary outcome
Live birth
Time frame: ≥20 weeks of gestation
Live birth defined as a delivery ≥20weeks gestation per transfer in the stimulated IVF cycles or in the first frozen-thawed embryo transfer cycle in those with elective freezing of all embryos
14 secondary outcomes
Embryo quality: embryo scoring standard
Time frame: On the third day after egg retrieval and before embryo transfer
Miscarriage rate
Time frame: ≤42 weeks of gestation
Implantation rate
Time frame: 2 weeks after embryo transfer
Positive serum human chorionic gonadotropin (hCG) level
Time frame: 2 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: ≥8 weeks
Multiple pregnancy rate
Time frame: ≥2 weeks after embryo transfer
Ectopic pregnancy rate
Time frame: ≥2 weeks after embryo transfer
Cumulative live birth rate
Time frame: within 6 months after randomization
Changes in markers of stress, anxiety
Time frame: ≤8 weeks of gestation
Health related quality of life(HRQoL)
Time frame: ≤8 weeks of gestation
Patient acceptability: acupuncture trust score
Time frame: On the day of embryo transfer
Side effects
Time frame: ≤ 8 weeks of gestation
Congenital abnormalities
Time frame: at 6 weeks postpartum
Pregnancy complications
Time frame: ≤42 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No. Subject's privacy is protected undoubtedly at the time of the informed consent signing
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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.
Xiaoke Wu, Ph.D study chair
First Affiliated Hospital in Heilongjiang University of Chinese Medicine
12 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 Chinese Herbal Medicine in people with In Vitro Fertilization, run by Heilongjiang University of Chinese Medicine at 12 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 4 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoke Wu, Ph.D (13796025599, xiaokewu2002@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: ≥20 weeks of gestation). 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 Sep 2021.