Clinical trial NCT04407871: Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization (IVFAct)
Official title: Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization - A Randomized Controlled Trial (IVFAct)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: In Vitro Fertilization
Keywords: In Vitro Fertilization
Chinese Herbal Medicine
Acupuncture
Live Birth
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 2728
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Women ≥20 to ≤40 years of age
2. Indications for IVF
3. Duration of infertility \>1 year
4. Undergoing IVF with an intention of fresh ET on day 3 or 5.

Exclusion Criteria:

1. Women with an intention to replace frozen embryos only.
2. Preimplantation genetic testing
3. History of recurrent miscarriages defined as having three consecutive miscarriages.
4. Having acupuncture or CHM for infertility within 3 months prior the IVF
5. Women with abnormal liver or renal function tests

Primary outcomes:
measure: Live birth
timeFrame: ≥20 weeks of gestation
Secondary outcomes:
measure: Embryo quality: embryo scoring standard
timeFrame: On the third day after egg retrieval and before embryo transfer
measure: Miscarriage rate
timeFrame: ≤42 weeks of gestation
measure: Implantation rate
timeFrame: 2 weeks after embryo transfer
measure: Positive serum human chorionic gonadotropin (hCG) level
timeFrame: 2 weeks after embryo transfer
measure: Ongoing pregnancy rate
timeFrame: ≥8 weeks
measure: Multiple pregnancy rate
timeFrame: ≥2 weeks after embryo transfer
measure: Ectopic pregnancy rate
timeFrame: ≥2 weeks after embryo transfer
measure: Cumulative live birth rate
timeFrame: within 6 months after randomization
measure: Changes in markers of stress, anxiety
timeFrame: ≤8 weeks of gestation
measure: Health related quality of life(HRQoL)
timeFrame: ≤8 weeks of gestation
measure: Patient acceptability: acupuncture trust score
timeFrame: On the day of embryo transfer
measure: Side effects
timeFrame: ≤ 8 weeks of gestation
measure: Congenital abnormalities
timeFrame: at 6 weeks postpartum
measure: Pregnancy complications
timeFrame: ≤42 weeks of gestation
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology
state: Hubei
city: Huai'an
country: China
facility: Huaian Maternal and Child Health Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing University Medical School (Nanjing Drum Tower Hospital)
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Dalian
country: China
facility: Dalian Municipal Women and Children's Medical Center
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: Xibei Women and Children's Hospital
state: Shanxi
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
Study officials:
affiliation: First Affiliated Hospital in Heilongjiang University of Chinese Medicine
name: Xiaoke Wu, Ph.D
role: STUDY_CHAIR
References: