The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF

Study Overview
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Brief Summary
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The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into two groups: acupuncture +IVF group and sham acupuncture +IVF group.

Official Title
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The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With Recurrent Implantation Failure: a Multi-center Randomized Controlled Clinical Trial

Conditions
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Repeated Implantation Failure

Intervention / Treatment
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* Device: acupuncture and IVF
* Device: sham acupuncture and IVF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Married women aged 25-40; Repeated implantation failure for unknown reasons (after 3 or more consecutive cycles of embryo transfer, or cumulative transfer of ≥6 high-quality cleavage embryos or 4 high-quality blastocysts without clinical pregnancy); Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (≥3BB); Estrogen and progesterone replacement therapy (HRT), endometrial thickness ≥7mm on the day of endometrial transformation. Exclusion Criteria: Patients who met any of the following conditions were not included. Those who prepare for PGD; Recipients of egg donors; Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism); patients with implantation failure due to known embryonic factors; Uterine lesions that may affect implantation (including uterine malformation, uterine tuberculosis, history of intrauterine adhesions, submucosal fibroids, adenomyosis, >4cm intramural fibroids) Repeated spontaneous abortion (2 or more fetal loss before 28 weeks of gestation); Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months; Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.; Hydrosalpinx untreated; BMI less than 18 and higher than 25kg/m2; People with previous history of needle sickness; Those who had previously participated in this study or had received acupuncture treatment in the past 3 months. Any situation that researchers consider inappropriate for participating in this study.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture and IVF<br>Acupuncture and IVF | Device: acupuncture and IVF<br>* Acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation and ending within 24 hours after embryo transfer.<br>|
| Sham Comparator: Sham acupuncture and IVF<br>Sham acupuncture and IVF | Device: sham acupuncture and IVF<br>* Sham acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation and ending within 24 hours after embryo transfer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPR | Clinical pregnancy rate | 1 month after ET | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OPR | ongoing pregnancy rate | 3 month after ET | 
| LBR | Live birth rate | 10 month after ET | 
| Biochemical indexes | Biochemical indexes | one year | 
| Questionnaire score | Questionnaire score | one year |