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临床试验/NCT07486297
NCT07486297尚未招募不适用

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

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2026年6月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
208
试验地点
1
主要终点
clinical pregnancy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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/m
  • Men with severe abnormalities in semen quality. Individuals with a history of needle phobia.

研究组 & 干预措施

Placebo group

Placebo Comparator

nonpenetrating placebo needles

干预措施: Placebo Group (Device)

acupuncture group

Experimental

indwelling intradermal needles

干预措施: Acupuncture group (Device)

结局指标

主要结局

clinical pregnancy

时间窗: 1 year

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

次要结局

  • β-hCG-positive pregnancy(1 year)
  • Endometrial thickness(1 year)
  • endometrial blood flow(1 year)
  • anxiety assessment(1 year)
  • depression assessment(1 year)
  • sleep quality assessment(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cui Hong Zheng

Principal Investigator, Clinical Professor

Huazhong University of Science and Technology

研究点 (1)

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