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ClinicalTrials.gov ID

NCT04407871

Lead Sponsor

Heilongjiang University of Chinese MedicineOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

2,728Estimated

Last Update Posted

Sep 23, 2021Actual

Start Date

Nov 1, 2021Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

Official Title

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

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.

• In Vitro Fertilization

• Acupuncture and Chinese Herbal Medicine

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Factorial Assignment

Masking

Quadruple

Lead Sponsor

Heilongjiang University of Chinese MedicineOTHER

18952171922

ccwang@cuhk.edu.hk