Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization (IVFAct)

In Vitro Fertilization Clinical Trial

— IVFAct  

Official title:

Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization - A Randomized Controlled Trial (IVFAct)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04407871
• Other study ID #: IVFAct
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Heilongjiang University of Chinese Medicine
• Contact: Xiaoke Wu, Ph.D
• Phone: 13796025599
• Email: xiaokewu2002[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

Other:
• Acupuncture 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

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