In Vitro Fertilization
Conditions
Keywords
In Vitro Fertilization, Chinese Herbal Medicine, Acupuncture, Live Birth
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.
Interventions
OTHERAcupuncture and Chinese Herbal Medicine
1\) 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.
Sponsors
Heilongjiang University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Miscarriage rate | ≤42 weeks of gestation | Cumulative miscarriage rate |
| Implantation rate | 2 weeks after embryo transfer | Cumulative implantation rate |
| Positive serum human chorionic gonadotropin (hCG) level | 2 weeks after embryo transfer | Positive serum hCG level 2 weeks after embryo transfer |
| Ongoing pregnancy rate | ≥8 weeks | Cumulative ongoing pregnancy rate |
| Multiple pregnancy rate | ≥2 weeks after embryo transfer | Cumulative multiple pregnancy rate |
| Ectopic pregnancy rate | ≥2 weeks after embryo transfer | Cumulative ectopic pregnancy rate |
| Embryo quality: embryo scoring standard | On the third day after egg retrieval and before embryo transfer | Embryo quality is judged by embryo scoring standard |
| 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) |
| 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) |
| Patient acceptability: acupuncture trust score | On the day of embryo transfer | Patient acceptability of acupuncture to be measured by acupuncture trust score |
| Side effects | ≤ 8 weeks of gestation | Side effects |
| Congenital abnormalities | at 6 weeks postpartum | Judging by prenatal ultrasound and postnatal physical examination |
| Pregnancy complications | ≤42 weeks of gestation | Complications of Pregnancy |
| Cumulative live birth rate | within 6 months after randomization | Cumulative live birth rate |
Countries
China
Contacts
Primary ContactXiaoke Wu, Ph.D
Outcome results
None listed