In Vitro Fertilization Clinical Trial
— IVFActOfficial 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.
Status | Not yet recruiting |
Enrollment | 2728 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Dalian Municipal Women and Children's Medical Center | Dalian | Liaoning |
China | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
China | The Chinese University of Hong Kong | Hong Kong | |
China | Huaian Maternal and Child Health Hospital | Huai'an | Jiangsu |
China | The First Hospital of Lanzhou University | Lanzhou | Gansu |
China | Jiangxi Maternal and Child Health Hospital | Nanchang | Jiangxi |
China | The First Affiliated Hospital of Nanjing University Medical School (Nanjing Drum Tower Hospital) | Nanjing | Jiangsu |
China | Shengjing Hospital of China Medical University | Shenyang | Liaoning |
China | Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology | Wuhan | Hubei |
China | Xibei Women and Children's Hospital | Xi'an | Shanxi |
China | Xuzhou Central Hospital | Xuzhou | Jiangsu |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Heilongjiang University of Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | =20 weeks of gestation | |
Secondary | Embryo quality: embryo scoring standard | Embryo quality is judged by embryo scoring standard | On the third day after egg retrieval and before embryo transfer | |
Secondary | Miscarriage rate | Cumulative miscarriage rate | =42 weeks of gestation | |
Secondary | Implantation rate | Cumulative implantation rate | 2 weeks after embryo transfer | |
Secondary | Positive serum human chorionic gonadotropin (hCG) level | Positive serum hCG level 2 weeks after embryo transfer | 2 weeks after embryo transfer | |
Secondary | Ongoing pregnancy rate | Cumulative ongoing pregnancy rate | =8 weeks | |
Secondary | Multiple pregnancy rate | Cumulative multiple pregnancy rate | =2 weeks after embryo transfer | |
Secondary | Ectopic pregnancy rate | Cumulative ectopic pregnancy rate | =2 weeks after embryo transfer | |
Secondary | Cumulative live birth rate | Cumulative live birth rate | within 6 months after randomization | |
Secondary | Changes in markers of stress, anxiety | To elucidate the anxiety level as measured with serum cortisol concentration and Stait-Trait Anxiety Inventory (STAI) | =8 weeks of gestation | |
Secondary | Health related quality of life(HRQoL) | To determine women's health related quality of life (HRQoL) by short-form 36 (SF36) | =8 weeks of gestation | |
Secondary | Patient acceptability: acupuncture trust score | Patient acceptability of acupuncture to be measured by acupuncture trust score | On the day of embryo transfer | |
Secondary | Side effects | Side effects | = 8 weeks of gestation | |
Secondary | Congenital abnormalities | Judging by prenatal ultrasound and postnatal physical examination | at 6 weeks postpartum | |
Secondary | Pregnancy complications | Complications of Pregnancy | =42 weeks of gestation |
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