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

Not Applicable

• Conditions: Recurrent Implantation Failure; Acupuncture
• Interventions: Procedure: acupuncture

• Registration Number: NCT04822207
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-30
• Study Start: 2021-05-01
• Last Update Submitted: 2021-08-08
• Last Update Posted: 2021-08-10
• Primary Completion: 2023-05-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 310

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture group	acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6 months	Clinical pregnancy will be defined as ultrasonographic evidence of an intrauterine sac with or without a fetal heart at the 6th gestational week.

Secondary Outcome Measures

Name	Time	Method
embryo implantation rate	6 months	The embryo implantation rate (IR) will be calculated as the number of gestational sacs per embryo transferred
biochemical pregnancy rate	6 months	Biochemical pregnancy will be defined by a serum HCG level ≥5.0 mIU/ml approximately 14 days after embryo transfer
live birth rate	12 mongths	Live birth rates were calculated based on the total number of live births \> 20 weeks' gestation over the total number of ongoing pregnancies.
early pregnancy loss rate	6 months	Early pregnancy loss will be considered pregnancy loss occurring after detection of a clinical pregnancy up to the 12th week of pregnancy
ongoing pregnancy rate	6 months	OPR was calculated by considering all viable intrauterine pregnancy progressing beyond 12 weeks of gestation.

Trial Locations

Locations (1)

Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China