RecruitingNot ApplicableNCT04533295

Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF

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


Sponsor

Huazhong University of Science and Technology

Enrollment

771 participants

Start Date

Nov 2, 2020

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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.

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Interventions

DEVICEacupuncture and IVF

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.

DEVICEsham acupuncture and IVF

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.

OTHERcontrol group

no acupuncture, only IVF


Locations(1)

Tongji Hospital,Tongji medical college,HUST

Wuhan, Hubei, China

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NCT04533295