Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF

NCT04533295 | Recruiting DMC

• 1 other identifier: 2019CR110
• Study Type: interventional
• Target: 771
• Locations: 1 country
• Sites: 1

Brief Summary

The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into three groups: acupuncture group (Acu.+IVF），sham acupuncture group（Sham Acu. +IVF），and the control group (only IVF).

Conditions

Repeated Implantation Failure

Outcome Measures

Primary Outcomes (1)

• CPR

  Clinical pregnancy rate

  1 year

Secondary Outcomes (5)

• OPR

  1 year

• LBR

  1 year

• Biochemical indexes

  before and after acupuncture treatment

• Questionnaire score

  before and after acupuncture treatment

• β-HCG positive rate

  1 year

Study Arms (3)

Acupuncture group

EXPERIMENTAL

Acupuncture + IVF.

Device: acupuncture and IVF

Sham acupuncture group

SHAM COMPARATOR

Sham acupuncture +IVF. We formulate and follow standardised step-by-step instructions and operations to use the same rituals in the acupuncture and sham acupuncture groups as far as possible.

Device: sham acupuncture and IVF

control group

OTHER

only IVF

Other: control group

Interventions

acupuncture and IVF DEVICE

Acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer.

Acupuncture group

sham acupuncture and IVF DEVICE

Sham acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer.

Sham acupuncture group

control group OTHER

no acupuncture, only IVF

control group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Married women aged 25-40;
• Repeated implantation failure for unknown reasons (experienced 2 or more embryo transfers of good-quality embryos without achieving clinical pregnancy);
• Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (≥3BB);
• Estrogen and progesterone replacement therapy (HRT), endometrial thickness ≥7mm on the day of endometrial transformation.

You may not qualify if:

• Patients who met any of the following conditions were not included.
• Those who prepare for PGD;
• Recipients of egg donors;
• Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism);
• patients with implantation failure due to known embryonic factors;
• Uterine lesions that may affect implantation (including uterine malformation, \>4cm intramural fibroids，submucosal fibroids, adenomyosis, uterine tuberculosis, intrauterine adhesions, etc.
• Repeated spontaneous abortion (2 or more fetal loss before 28 weeks of gestation);
• Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months;
• Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;
• Hydrosalpinx untreated;
• BMI less than 18 or higher than 25kg/m2;
• People with previous history of needle sickness;
• Those who have previously participated in this study or received acupuncture treatment in the past 3 months.
• Any situation that researchers consider inappropriate for participating in this study.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital,Tongji medical college,HUST

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy; Control Groups

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Minming Zhang, professor

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cuihong Zheng, professor

CONTACT

86-27-83663275; chzheng@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To maintain blinding in patients, outcome assessors, and statisticians, the allocation sequence was concealed until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: November 2, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)