Effect of Acupuncture on the Clinical Outcome of IVF-ET in Patients With Recurrent Implantation Failure

ShangHai Ji Ai Genetics & IVF Institute

Status: Unknown

Conditions: Acupuncture; Recurrent Implantation Failure

Treatments: Procedure: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04822207

JIAI 2021-01

Details and patient eligibility

About

In order to explore the effect of acupuncture on the clinical outcome of IVF-ET in patients with recurrent implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. In the control group, those patients do not receive any treatments during embryo transfer cycle. Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.

Full description

In the field of assisted reproduction techonology, there are still 10% of patients with recurrent implantation failure. In order to explore the effect of acupuncture on the clinical outcome of IVF-ET in patients with recurrent implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. In the control group, those patients do not receive any treatments during embryo transfer cycle. Both of two group patients are checked including endometrial receptivity index and fill in SAS anxiety scale form. Statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (embryo implantation rate, biochemical pregnancy rate, early pregnancy loss rate, ongoing pregnancy rate, live birth rate)are done.

Enrollment: 310 estimated patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A: ≥ 3 times embryo transfer failures，and at least accumulated 4 high-quality embryos were transferred

B: Two times consecutive embryo transfers failures, at least accumulated 4 high-quality embryos were transferred

2. Undergo IVF / ICSI / PGT;

3. Transfer 1-2 D3 cleavage embryos or blastocysts in IVF / ICSI and transfer 1 blastocyst in PGT;

4. 20-38 years old female

5. Sign the informed consent voluntarily.

Exclusion criteria

1. Contraindications for pregnancy or assisted reproductive technology;
2. Chromosome abnormality of husband or wife (except polymorphism);
3. Abnormal gene diseases;
4. Untreated of uterine diseases that affect the uterine cavity morphology (uterine malformation, submucous myoma, adenomyosis, endometriosis and endometriosis etc.);
5. AMH < 1.1ng/ml or AFC < 7;
6. The most thickness of endometrium is less than 7 millimeter;
7. Those who have more than 2 times clinical pregnancy abortion;
8. Patients with serious primary diseases including cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and mental diseases
9. The treatment (such as acupuncture and traditional Chinese Medicine) related to help pregnancy had been carried out in the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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310 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

In the acupuncture group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. These patients should be checked including endometrial receptivity index and fill in SAS anxiety scale form.

Treatment:

Procedure: acupuncture

Control group

No Intervention group

Description:

In the control group, these patients do not receive any treatments during embryo transfer cycle. These patients should be checked including endometrial receptivity index and fill in SAS anxiety scale form.