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NCT Number: NCT04533295

Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF

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).

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Key information

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital,Tongji medical college,HUST

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Cuihong Zheng, professor

CONTACT

Minming Zhang, professor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

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.

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.

Control Group

Other

no acupuncture, only IVF

Primary outcomes

  1. CPR

    Time frame: 1 year

    Clinical pregnancy rate

Secondary outcomes

  1. OPR

    Time frame: 1 year

    ongoing pregnancy rate

  2. LBR

    Time frame: 1 year

    Live birth rate

  3. Biochemical indexes

    Time frame: before and after acupuncture treatment

    Biochemical indexes

  4. Questionnaire score

    Time frame: before and after acupuncture treatment

    Questionnaire score

  5. β-HCG positive rate

    Time frame: 1 year

    level of serum β-HCG positive rate

Study contacts

Contact information is provided by the study sponsor or research team.

Cuihong Zheng, professor

CONTACT

[email protected]

86-27-83663275

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

Effect of Acupuncture on IVF Pregnancy Outcomes for Women With Recurrent Implantation Failure: a Multi-center Randomized Controlled Clinical Trial

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2020
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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