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

Primary Purpose

Acupuncture, Recurrent Implantation Failure

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
ShangHai Ji Ai Genetics & IVF Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture focused on measuring acupuncture, recurrent implantation failure

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

embryo implantation rate
The embryo implantation rate (IR) will be calculated as the number of gestational sacs per embryo transferred
biochemical pregnancy rate
Biochemical pregnancy will be defined by a serum HCG level ≥5.0 mIU/ml approximately 14 days after embryo transfer
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
ongoing pregnancy rate
OPR was calculated by considering all viable intrauterine pregnancy progressing beyond 12 weeks of gestation.
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.

Full Information

First Posted
March 25, 2021
Last Updated
August 8, 2021
Sponsor
ShangHai Ji Ai Genetics & IVF Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04822207
Brief Title
Effect of Acupuncture on the Clinical Outcome of IVF-ET in Patients With Recurrent Implantation Failure
Official Title
Effect of Acupuncture on the Clinical Outcome of IVF-ET in Patients With Recurrent Implantation Failure: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ShangHai Ji Ai Genetics & IVF Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Recurrent Implantation Failure
Keywords
acupuncture, recurrent implantation failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Clinical pregnancy will be defined as ultrasonographic evidence of an intrauterine sac with or without a fetal heart at the 6th gestational week.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
embryo implantation rate
Description
The embryo implantation rate (IR) will be calculated as the number of gestational sacs per embryo transferred
Time Frame
6 months
Title
biochemical pregnancy rate
Description
Biochemical pregnancy will be defined by a serum HCG level ≥5.0 mIU/ml approximately 14 days after embryo transfer
Time Frame
6 months
Title
early pregnancy loss rate
Description
Early pregnancy loss will be considered pregnancy loss occurring after detection of a clinical pregnancy up to the 12th week of pregnancy
Time Frame
6 months
Title
ongoing pregnancy rate
Description
OPR was calculated by considering all viable intrauterine pregnancy progressing beyond 12 weeks of gestation.
Time Frame
6 months
Title
live birth rate
Description
Live birth rates were calculated based on the total number of live births > 20 weeks' gestation over the total number of ongoing pregnancies.
Time Frame
12 mongths

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Contraindications for pregnancy or assisted reproductive technology; Chromosome abnormality of husband or wife (except polymorphism); Abnormal gene diseases; Untreated of uterine diseases that affect the uterine cavity morphology (uterine malformation, submucous myoma, adenomyosis, endometriosis and endometriosis etc.); AMH < 1.1ng/ml or AFC < 7; The most thickness of endometrium is less than 7 millimeter; Those who have more than 2 times clinical pregnancy abortion; Patients with serious primary diseases including cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and mental diseases The treatment (such as acupuncture and traditional Chinese Medicine) related to help pregnancy had been carried out in the last 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbi Zhang, Doctor
Phone
+8602163459977
Email
jackeyzhang0905@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
He Li, Doctor
Phone
+8602163459977
Email
lihe198900@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoxi Sun
Organizational Affiliation
Obstetrics and Gynecology Hospital affiliated to Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbi Zhang, Doctor
Email
jackeyzhang0905@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16600232
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. doi: 10.1016/j.fertnstert.2005.08.070. Epub 2006 Apr 5.
Results Reference
background
PubMed Identifier
11937123
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. doi: 10.1016/s0015-0282(01)03273-3.
Results Reference
background
PubMed Identifier
16616748
Citation
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.
Results Reference
background

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

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