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

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Repeated Implantation Failure

Treatments: Device: sham acupuncture and IVF; Device: acupuncture and IVF

Study type: Interventional

Funder types: Other

Identifiers

NCT04533295

2019CR110

Details and patient eligibility

About

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.

Enrollment: 514 estimated patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Married women aged 25-40;
2. 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);
3. Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (≥3BB);
4. 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.

1. Those who prepare for PGD;
2. Recipients of egg donors;
3. Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism);
4. patients with implantation failure due to known embryonic factors;
5. Uterine lesions that may affect implantation (including uterine malformation, uterine tuberculosis, history of intrauterine adhesions, submucosal fibroids, adenomyosis, >4cm intramural fibroids)
6. Repeated spontaneous abortion (2 or more fetal loss before 28 weeks of gestation);
7. 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;
8. Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;
9. Hydrosalpinx untreated;
10. BMI less than 18 and higher than 25kg/m2;
11. People with previous history of needle sickness;
12. Those who had previously participated in this study or had received acupuncture treatment in the past 3 months.
13. Any situation that researchers consider inappropriate for participating in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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514 participants in 2 patient groups

Acupuncture and IVF

Experimental group

Description:

Acupuncture and IVF

Treatment:

Device: acupuncture and IVF

Sham acupuncture and IVF

Sham Comparator group

Description:

Sham acupuncture and IVF

Treatment:

Device: sham acupuncture and IVF