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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acupuncture; Recurrent Implantation Failure
• Intervention / Treatment: Procedure: acupuncture

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 Type: Interventional
• Enrollment (Anticipated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenbi Zhang, Doctor; Phone Number: +8602163459977; Email: jackeyzhang0905@163.com
• Study Contact Backup: Name: He Li, Doctor; Phone Number: +8602163459977; Email: lihe198900@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University
      • Contact: Wenbi Zhang, Doctor; Email: jackeyzhang0905@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acupuncture group; 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.	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.
NO_INTERVENTION: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
embryo implantation rate	The embryo implantation rate (IR) will be calculated as the number of gestational sacs per embryo transferred	6 months
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
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
ongoing pregnancy rate	OPR was calculated by considering all viable intrauterine pregnancy progressing beyond 12 weeks of gestation.	6 months
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

Collaborators and Investigators

• Sponsor: ShangHai Ji Ai Genetics & IVF Institute
• Investigators: Study Chair: Xiaoxi Sun, Obstetrics and Gynecology Hospital affiliated to Fudan University

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.fertnstert.2005.08.070. Epub 2006 Apr 5.
• 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. doi: 10.1016/s0015-0282(01)03273-3.
• 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. doi: 10.1016/j.fertnstert.2005.09.062. Epub 2006 Apr 17.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (ACTUAL): March 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: acupuncture; recurrent implantation failure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: JIAI 2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No