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

Acupuncture Clinical Trial

Official title:

Effect of Acupuncture on the Clinical Outcome of IVF-ET in Patients With Recurrent Implantation Failure: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822207
• Other study ID #: JIAI 2021-01
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: Wenbi Zhang, Doctor
• Phone: +8602163459977
• Email: jackeyzhang0905[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Recurrent Implantation Failure

Intervention

Procedure:
• acupuncture
Patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. Every acupuncture lasts 20 minutes.

Locations

Country	Name	City	State
China	Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (3)

Dieterle S, Ying G, Hatzmann W, Neuer A. Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study. Fertil Steril. 2006 May;85(5):1347-51. Epub 2006 Apr 17. — View Citation

Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertil Steril. 2002 Apr;77(4):721-4. — View Citation

Westergaard LG, Mao Q, Krogslund M, Sandrini S, Lenz S, Grinsted J. Acupuncture on the day of embryo transfer significantly improves the reproductive outcome in infertile women: a prospective, randomized trial. Fertil Steril. 2006 May;85(5):1341-6. Epub 2006 Apr 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Clinical pregnancy will be defined as ultrasonographic evidence of an intrauterine sac with or without a fetal heart at the 6th gestational week.	6 months
Secondary	embryo implantation rate	The embryo implantation rate (IR) will be calculated as the number of gestational sacs per embryo transferred	6 months
Secondary	biochemical pregnancy rate	Biochemical pregnancy will be defined by a serum HCG level =5.0 mIU/ml approximately 14 days after embryo transfer	6 months
Secondary	early pregnancy loss rate	Early pregnancy loss will be considered pregnancy loss occurring after detection of a clinical pregnancy up to the 12th week of pregnancy	6 months
Secondary	ongoing pregnancy rate	OPR was calculated by considering all viable intrauterine pregnancy progressing beyond 12 weeks of gestation.	6 months
Secondary	live birth rate	Live birth rates were calculated based on the total number of live births > 20 weeks' gestation over the total number of ongoing pregnancies.	12 mongths