Not yet recruiting NCT07486297
Effect of Acupuncture on the Success Rate in Patients With Recurrent Implantation Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo Group, Acupuncture group.
- Who it may be relevant to
- Registry conditions: Implantation Failure. Basic parameters: 20 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Randomized Controlled Trial Evaluating the Effect of Acupuncture on the Success Rate in Patients With Recurrent Implantation Failure
Overview
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.
Interventions
- Device Placebo Group
nonpenetrating placebo needles - Device Acupuncture group
indwelling intradermal needles
Primary outcome measures
- clinical pregnancy [Time frame: 1 year]
Secondary outcome measures (6)
- β-hCG-positive pregnancy [Time frame: 1 year]
- Endometrial thickness [Time frame: 1 year]
- endometrial blood flow [Time frame: 1 year]
- anxiety assessment [Time frame: 1 year]
- depression assessment [Time frame: 1 year]
- sleep quality assessment [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07486297 · TJ-IRB202510016