Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF

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

The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into three groups: acupuncture group (Acu.+IVF），sham acupuncture group（Sham Acu. +IVF），and the control group (only IVF).

Study Overview

• Status: Recruiting
• Conditions: Repeated Implantation Failure
• Intervention / Treatment: Device: acupuncture and IVF; Device: sham acupuncture and IVF; Other: control group

• Study Type: Interventional
• Enrollment (Estimated): 771
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cuihong Zheng, professor; Phone Number: 86-27-83663275; Email: chzheng@tjh.tjmu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital,Tongji medical college,HUST
      • Contact: Cuihong Zheng, professor
      • Principal Investigator: Minming Zhang, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Married women aged 25-40;
2. Repeated implantation failure for unknown reasons (experienced 2 or more embryo transfers of good-quality embryos without achieving clinical pregnancy);
3. Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (≥3BB);
4. Estrogen and progesterone replacement therapy (HRT), endometrial thickness ≥7mm on the day of endometrial transformation.

Exclusion Criteria:

Patients who met any of the following conditions were not included.

1. Those who prepare for PGD;
2. Recipients of egg donors;
3. Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism);
4. patients with implantation failure due to known embryonic factors;
5. Uterine lesions that may affect implantation (including uterine malformation, >4cm intramural fibroids，submucosal fibroids, adenomyosis, uterine tuberculosis, intrauterine adhesions, etc.
6. Repeated spontaneous abortion (2 or more fetal loss before 28 weeks of gestation);
7. Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months;
8. Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;
9. Hydrosalpinx untreated;
10. BMI less than 18 or higher than 25kg/m2;
11. People with previous history of needle sickness;
12. Those who have previously participated in this study or received acupuncture treatment in the past 3 months.
13. Any situation that researchers consider inappropriate for participating in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; Acupuncture + IVF.	Device: acupuncture and IVF; Acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer.
Sham Comparator: Sham acupuncture group; Sham acupuncture +IVF. We formulate and follow standardised step-by-step instructions and operations to use the same rituals in the acupuncture and sham acupuncture groups as far as possible.	Device: sham acupuncture and IVF; Sham acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer.
Other: control group; only IVF	Other: control group; no acupuncture, only IVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPR	Clinical pregnancy rate	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OPR	ongoing pregnancy rate	1 year
LBR	Live birth rate	1 year
Biochemical indexes	Biochemical indexes	before and after acupuncture treatment
Questionnaire score	Questionnaire score	before and after acupuncture treatment
β-HCG positive rate	level of serum β-HCG positive rate	1 year

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Minming Zhang, professor, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Therapeutics; Complementary Therapies; Control Groups; Acupuncture Therapy
• Other Study ID Numbers: 2019CR110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No