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

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Implantation Failure

Treatments: Device: Placebo Group; Device: Acupuncture group

Study type: Interventional

Funder types: Other

Identifiers

NCT07486297

TJ-IRB202510016

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

nonpenetrating placebo needles

Treatment:

Device: Placebo Group

acupuncture group

Experimental group

Description:

indwelling intradermal needles

Treatment:

Device: Acupuncture group