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

NCT07486297 | Not Yet Recruiting DMC

• 1 other identifier: TJ-IRB202510016
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Implantation Failure

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy

  defined as ultrasonographic detection of an intrauterine gestational sac following embryo transfer

  1 year

Secondary Outcomes (6)

• β-hCG-positive pregnancy

  1 year

• Endometrial thickness

  1 year

• endometrial blood flow

  1 year

• anxiety assessment

  1 year

• depression assessment

  1 year

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

nonpenetrating placebo needles

Device: Placebo Group

acupuncture group

EXPERIMENTAL

indwelling intradermal needles

Device: Acupuncture group

Interventions

Placebo Group DEVICE

nonpenetrating placebo needles

Placebo group

Acupuncture group DEVICE

indwelling intradermal needles

acupuncture group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Individuals planning to undergo preimplantation genetic diagnosis (PGD).
• Recipients of egg donations.
• Chromosomal abnormalities in either spouse or one partner (excluding chromosomal polymorphisms).
• Patients with known embryo-related factors leading to implantation failure.
• 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).
• Recurrent spontaneous abortions (loss of a fetus before 28 weeks of gestation occurring twice or more).
• 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.
• Individuals with untreated hydrosalpinx;
• Individuals with a Body Mass Index (BMI) below 18 and above 25 kg/m2.
• Men with severe abnormalities in semen quality. Individuals with a history of needle phobia.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 20, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)