Implantation Failure
Conditions
Brief summary
To conduct a multi-center, randomized, controlled clinical study aimed at formally evaluating the impact of different acupuncture methods on the success rate in patients with recurrent implantation failure
Interventions
DEVICEPlacebo Group
nonpenetrating placebo needles
DEVICEacupuncture group 1
indwelling intradermal needles
DEVICEacupuncture group 2
combining fire needle and regular acupuncture
Sponsors
Cui Hong Zheng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 39 Years
Healthy volunteers
No
Inclusion criteria
1. Meets the criteria for RIF diagnosis (≥ 3 instances of unsuccessful transfer of high-quality embryos). 2. Age: \< 40 years. 3. Planning for a cycle involving the transfer of frozen-thawed embryos (FET). 4. Possession of a transplantable frozen blastocyst (≥3BB). 5. 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. Those with significant abnormalities in immunity or coagulation. 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. 11. Individuals with a history of needle phobia. 12. Individuals who have previously participated in this study or received acupuncture treatment within the past three months; 13. Any other conditions deemed unsuitable for participation by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy | 2 years | defined as ultrasonographic detection of an intrauterine gestational sac following embryo transfer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| β-hCG-positive pregnancy | 2 years | defined as serum β-hCG concentration \>10 mIU/mL on day 14 post-transfer |
| live birth | 3 years | defined as the delivery of 1 or more living infants at greater than 20 weeks' gestation or birth weight of at least 400 g |
Countries
China
Contacts
CONTACTPu Zhou
Outcome results
None listed