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

NCT04407871 | Unknown DMC

• 1 other identifier: IVFAct
• Study Type: interventional
• Target: 2,728
• Locations: 1 country
• Sites: 12

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.

Conditions

In Vitro Fertilization

Keywords

In Vitro Fertilization; Chinese Herbal Medicine; Acupuncture; Live Birth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Embryo quality: embryo scoring standard

  On the third day after egg retrieval and before embryo transfer

• Miscarriage rate

  ≤42 weeks of gestation

• Implantation rate

  2 weeks after embryo transfer

• Positive serum human chorionic gonadotropin (hCG) level

  2 weeks after embryo transfer

• Ongoing pregnancy rate

  ≥8 weeks

Study Arms (4)

acupuncture and CHM

EXPERIMENTAL

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.

Other: Acupuncture and Chinese Herbal Medicine

acupuncture and placebo CHM

PLACEBO COMPARATOR

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.

Other: Acupuncture and Chinese Herbal Medicine

control acupuncture and CHM

PLACEBO COMPARATOR

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.

Other: Acupuncture and Chinese Herbal Medicine

control acupuncture and placebo CHM

PLACEBO COMPARATOR

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.

Other: Acupuncture and Chinese Herbal Medicine

Interventions

Acupuncture and Chinese Herbal Medicine OTHER

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.

acupuncture and CHM; acupuncture and placebo CHM; control acupuncture and CHM; control acupuncture and placebo CHM

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Undergoing IVF
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heilongjiang University of Chinese Medicine: lead

Study Sites (12)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, China

Location

Huaian Maternal and Child Health Hospital

Huai'an, Jiangsu, China

Location

The First Affiliated Hospital of Nanjing University Medical School (Nanjing Drum Tower Hospital)

Nanjing, Jiangsu, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Location

Dalian Municipal Women and Children's Medical Center

Dalian, Liaoning, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Xibei Women and Children's Hospital

Xi’an, Shanxi, China

Location

The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Xiaoke Wu, Ph.D

  First Affiliated Hospital in Heilongjiang University of Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Xiaoke Wu, Ph.D

CONTACT

13796025599; xiaokewu2002@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Obstetrics and Gynecology Department

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 29, 2020
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)