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Recruiting NCT04533295

Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF

No phase Interventional Repeated Implantation Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: acupuncture and IVF, sham acupuncture and IVF, control group.
Who it may be relevant to
Registry conditions: Repeated Implantation Failure. Basic parameters: 25 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • Device acupuncture 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.
  • Device sham 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.
  • Other control group
    no acupuncture, only IVF

Primary outcome measures

  • CPR [Time frame: 1 year]
Secondary outcome measures (5)
  • OPR [Time frame: 1 year]
  • LBR [Time frame: 1 year]
  • Biochemical indexes [Time frame: before and after acupuncture treatment]
  • Questionnaire score [Time frame: before and after acupuncture treatment]
  • β-HCG positive rate [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital,Tongji medical college,HUST — Wuhan

Identifiers

NCT: NCT04533295 · 2019CR110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗