Implantation Failure
Conditions
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.
Interventions
DEVICEPlacebo Group
nonpenetrating placebo needles
DEVICEAcupuncture group
indwelling intradermal needles
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy | 1 year | defined as ultrasonographic detection of an intrauterine gestational sac following embryo transfer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| β-hCG-positive pregnancy | 1 year | defined as serum β-hCG concentration \>10 mIU/mL on day 14 post-transfer |
| Endometrial thickness | 1 year | Endometrial thickness on Transformation Day |
| endometrial blood flow | 1 year | — |
| anxiety assessment | 1 year | — |
| depression assessment | 1 year | — |
| sleep quality assessment | 1 year | — |
Countries
China
Outcome results
None listed