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

NCT04822207 | Unknown DMC

• 1 other identifier: JIAI 2021-01
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Recurrent Implantation Failure

Keywords

acupuncture; recurrent implantation failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• embryo implantation rate

  6 months

• biochemical pregnancy rate

  6 months

• early pregnancy loss rate

  6 months

• ongoing pregnancy rate

  6 months

• live birth rate

  12 mongths

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

acupuncture PROCEDURE

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.

Acupuncture group

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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
• \. Undergo IVF / ICSI / PGT;
• \. Transfer 1-2 D3 cleavage embryos or blastocysts in IVF / ICSI and transfer 1 blastocyst in PGT;
• \. 20-38 years old female
• \. Sign the informed consent voluntarily.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 16600232 BACKGROUND

• 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.

  PMID: 11937123 BACKGROUND

• 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.

  PMID: 16616748 BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Xiaoxi Sun

  Obstetrics and Gynecology Hospital affiliated to Fudan University

  STUDY CHAIR

Central Study Contacts

Wenbi Zhang, Doctor

CONTACT

+8602163459977; jackeyzhang0905@163.com

He Li, Doctor

CONTACT

+8602163459977; lihe198900@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 30, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: December 31, 2023
• Last Updated: August 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)