Actively Recruiting

Phase Not Applicable
Age: 25Years - 40Years
FEMALE
ID04533295

Effect of Acupuncture on IVF Pregnancy Outcomes for Women With Recurrent Implantation Failure: a Multi-center Randomized Controlled Clinical Trial

Led by Huazhong University of Science and Technology · Updated on 2026-03-10

771

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of acupuncture on pregnancy outcomes in women with recurrent implantation failure (RIF) undergoing in vitro fertilization (IVF). This randomized, placebo-controlled multicenter trial takes place in five centers in China and aims to compare acupuncture combined with IVF, sham acupuncture combined with IVF, and IVF alone. The study focuses on women aged 25 to 40 who have experienced repeated implantation failure for unknown reasons despite multiple embryo transfers. Participants are randomly assigned to one of three groups: acupuncture plus IVF, sham acupuncture plus IVF, or IVF only. Acupuncture and sham acupuncture treatments are performed three times a week for 30 minutes each session, beginning on the 5th day of menstruation before the transfer cycle and ending within 24 hours after embryo transfer. The control group receives only the IVF procedure without acupuncture. During the study, researchers will monitor clinical pregnancy rates as the primary outcome within one year. Secondary outcomes include ongoing pregnancy rates, live birth rates, biochemical indexes, questionnaire scores before and after acupuncture treatment, and the rate of positive β-HCG within one year. Participants will be assessed through these measures to evaluate the impact of acupuncture on IVF pregnancy outcomes.

CONDITIONS

Brief Title

Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF

Who Can Participate

Age: 25Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Married women aged between 25 and 40 years
  • Women with repeated implantation failure for unknown reasons, defined as 2 or more embryo transfers of good-quality embryos without achieving clinical pregnancy
  • Presence of transplantable Day 3 high-quality frozen embryos or frozen blastocysts (grade BB or higher)
  • Use of estrogen and progesterone replacement therapy with endometrial thickness of at least 7mm on the day of endometrial transformation
Not Eligible

You will not qualify if you...

  • Preparing for preimplantation genetic diagnosis (PGD)
  • Recipients of egg donors
  • Chromosomal abnormalities in one or both partners, excluding chromosome polymorphisms
  • Implantation failure due to known embryonic factors
  • Uterine lesions affecting implantation, including uterine malformation, intramural fibroids larger than 4cm, submucosal fibroids, adenomyosis, uterine tuberculosis, and intrauterine adhesions
  • Repeated spontaneous abortion with 2 or more fetal losses before 28 weeks of gestation
  • Other endocrine diseases such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease with poor hormone control in the last 3 months
  • Diagnosed autoimmune diseases like systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome
  • Untreated hydrosalpinx
  • Body mass index (BMI) less than 18 or greater than 25 kg/m2
  • History of needle sickness
  • Previous participation in this study or acupuncture treatment in the past 3 months
  • Any condition considered inappropriate by researchers for participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - From the 5th day of menstruation before the IVF cycle until within 24 hours after embryo transfer

Participants receive acupuncture or sham acupuncture three times a week for 30 minutes each session, starting from the 5th day of menstruation before the IVF cycle and ending within 24 hours after embryo transfer. The control group undergoes IVF without acupuncture.

Multiple visits three times a week for acupuncture or sham acupuncture sessions

Follow-up

Duration - Up to 1 year

Participants are monitored for pregnancy outcomes and biochemical indexes up to 1 year after treatment.

Follow-up visits as scheduled for pregnancy outcome assessments

Trial Site Locations

Total: 1 location

1

Tongji Hospital,Tongji medical college,HUST

Wuhan, Hubei, China, 430030

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Research Team

C

Cuihong Zheng, professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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