Effect of Acupuncture on the Success Rate in Patients With Recurrent Implantation Failure

A Multicenter Randomized Controlled Trial Evaluating the Effect of Acupuncture on the Success Rate in Patients With Recurrent Implantation Failure

To conduct a multi-center, randomized, controlled clinical study aimed at formally evaluating the impact of pressing therapy on the success rate in patients with recurrent implantation failure.

Study Overview

• Status: Not yet recruiting
• Conditions: Implantation Failure
• Intervention / Treatment: Device: Placebo Group; Device: Acupuncture group

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Pu Zhou; Phone Number: +8602783662379; Email: tongjihlunli@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Meets the criteria for RIF diagnosis (≥ 2 instances of unsuccessful transfer of high-quality embryos).
2. Age: 20 to 40 years old.
3. Planning for a cycle involving the transfer of frozen-thawed embryos (FET).
4. Possession of a transplantable D3 frozen embryo (≥6 cells) or a frozen blastocyst (≥3BC).
5. Estradiol-progesterone replacement therapy: endometrial thickness ≥ 7 mm within the period of endometrial transformation.

Exclusion Criteria:

1. Individuals planning to undergo preimplantation genetic diagnosis (PGD).
2. Recipients of egg donations.
3. Chromosomal abnormalities in either spouse or one partner (excluding chromosomal polymorphisms).
4. Patients with known embryo-related factors leading to implantation failure.
5. Abnormalities of the uterus that may affect implantation (including uterine malformations, uterine tuberculosis, submucosal myomas, severe uterine adhesions, severe uterine endometriosis, myomas with a diameter of ≥4 cm, and so on).
6. Recurrent spontaneous abortions (loss of a fetus before 28 weeks of gestation occurring twice or more).
7. Individuals with other endocrine disorders, such as thyroid disorders, hyperprolactinemia, insulin resistance, diabetes, and adrenal disorders, whose hormone levels have not been well-controlled over the past 3 months.
8. Individuals with untreated hydrosalpinx;
9. Individuals with a Body Mass Index (BMI) below 18 and above 25 kg/m2.
10. Men with severe abnormalities in semen quality. Individuals with a history of needle phobia.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; nonpenetrating placebo needles	Device: Placebo Group; nonpenetrating placebo needles
Experimental: acupuncture group; indwelling intradermal needles	Device: Acupuncture group; indwelling intradermal needles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy	defined as ultrasonographic detection of an intrauterine gestational sac following embryo transfer	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
β-hCG-positive pregnancy	defined as serum β-hCG concentration >10 mIU/mL on day 14 post-transfer	1 year
Endometrial thickness	Endometrial thickness on Transformation Day	1 year
endometrial blood flow		1 year
anxiety assessment		1 year
depression assessment		1 year
sleep quality assessment		1 year

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: TJ-IRB202510016

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