Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization (IVFAct)
- Conditions
- In Vitro Fertilization
- Interventions
- Other: Acupuncture and Chinese Herbal Medicine
- Registration Number
- NCT04407871
- Lead Sponsor
- Heilongjiang University of Chinese Medicine
- Brief 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. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 2728
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description acupuncture and CHM Acupuncture and Chinese Herbal Medicine 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. acupuncture and placebo CHM Acupuncture and Chinese Herbal Medicine 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. control acupuncture and placebo CHM Acupuncture and Chinese Herbal Medicine 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. control acupuncture and CHM Acupuncture and Chinese Herbal Medicine 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.
- Primary Outcome Measures
Name Time Method Live birth ≥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
- Secondary Outcome Measures
Name Time Method Embryo quality: embryo scoring standard On the third day after egg retrieval and before embryo transfer Embryo quality is judged by embryo scoring standard
Miscarriage rate ≤42 weeks of gestation Cumulative miscarriage rate
Ongoing pregnancy rate ≥8 weeks Cumulative ongoing pregnancy rate
Multiple pregnancy rate ≥2 weeks after embryo transfer Cumulative multiple pregnancy rate
Implantation rate 2 weeks after embryo transfer Cumulative implantation rate
Side effects ≤ 8 weeks of gestation Side effects
Pregnancy complications ≤42 weeks of gestation Complications of Pregnancy
Ectopic pregnancy rate ≥2 weeks after embryo transfer Cumulative ectopic pregnancy rate
Cumulative live birth rate within 6 months after randomization Cumulative live birth rate
Health related quality of life(HRQoL) ≤8 weeks of gestation To determine women's health related quality of life (HRQoL) by short-form 36 (SF36)
Changes in markers of stress, anxiety ≤8 weeks of gestation To elucidate the anxiety level as measured with serum cortisol concentration and Stait-Trait Anxiety Inventory (STAI)
Congenital abnormalities at 6 weeks postpartum Judging by prenatal ultrasound and postnatal physical examination
Patient acceptability: acupuncture trust score On the day of embryo transfer Patient acceptability of acupuncture to be measured by acupuncture trust score
Positive serum human chorionic gonadotropin (hCG) level 2 weeks after embryo transfer Positive serum hCG level 2 weeks after embryo transfer
Trial Locations
- Locations (12)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Nanjing University Medical School (Nanjing Drum Tower Hospital)
🇨🇳Nanjing, Jiangsu, China
Huaian Maternal and Child Health Hospital
🇨🇳Huai'an, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
🇨🇳Nanchang, Jiangxi, China
Dalian Municipal Women and Children's Medical Center
🇨🇳Dalian, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Xibei Women and Children's Hospital
🇨🇳Xi'an, Shanxi, China
The Chinese University of Hong Kong
🇨🇳Hong Kong, China