Acupuncture to improve IVF pregnancy chances for women with repeated implantation failure

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

This study will test whether adding real acupuncture to IVF helps women with repeated implantation failure (two or more failed good-quality embryo transfers) get pregnant compared with sham acupuncture or IVF alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 771 (estimated)
• Ages: 25 Years to 40 Years
• Sex: Female
• Sponsor: Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT04533295 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled multicenter trial in China randomly assigns eligible women to one of three groups: acupuncture plus IVF, sham acupuncture plus IVF, or IVF alone. Participants are married women aged 25–40 with unexplained repeated implantation failure and at least transferable frozen embryos, undergoing an HRT cycle with endometrial thickness ≥7 mm. The intervention involves in-person acupuncture sessions around embryo transfer at participating centers, with clinical pregnancy outcomes compared across groups. Major exclusions include recipients of donor eggs, couples with chromosomal abnormalities, known embryonic causes of implantation failure, significant uterine lesions, preparation for PGD, or recurrent spontaneous abortion.

Who should consider this trial

Good fit: Married women aged 25–40 with unexplained repeated implantation failure who have at least one high-quality frozen Day-3 embryo or blastocyst and are preparing for an HRT embryo transfer with endometrial thickness ≥7 mm.

Not a fit: Patients unlikely to benefit include those using donor eggs, preparing for PGD, couples with known chromosomal abnormalities or known embryonic causes of implantation failure, and those with major uterine lesions or recurrent spontaneous abortion.

Why it matters

Potential benefit: If successful, adding acupuncture could increase implantation and clinical pregnancy rates after IVF for women with unexplained repeated implantation failure.

How similar studies have performed: Prior randomized trials and meta-analyses of acupuncture around IVF have produced mixed results, with some reporting small benefits and others finding no clear effect, so the approach remains controversial.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital,Tongji medical college,HUST — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Minming Zhang, professor — Huazhong University of Science and Technology
• Study coordinator: Cuihong Zheng, professor

Conditions Repeated Implantation Failure