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Acupuncture in the Freeze-all IVF Cycle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04931355
Recruitment Status : Not yet recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Information provided by (Responsible Party):
Peking University Third Hospital

Brief Summary:
In the early stage, our team found that Acupuncture intervention in freeze-all IVF cycles can improve the clinical pregnancy rate. In order to further study the role of Acupuncture in improving the pregnancy outcome of IVF-ET in infertility. A randomized controlled clinical trial will be used in this study. 90 infertile patients are randomly divided into two groups. The control group will be treated with conventional modern medicine, and the treatment group will be treated with Acupuncture on the basis of conventional modern medicine. The intervention starts from the 5th day of the menstrual cycle and lasts to the day before IVF-ET. The number of oocytes, antral follicles, AMH, serum FSH, and clinical pregnancy rate will be observed to evaluate the effect of Acupuncture on the improvement of pregnancy outcome. In addition, all of the participants will be asked to complete the self-evaluation of the anxiety/depression scale on the 7th day of the menstrual cycle, before and after transplantation, to analyze the emotional changes of the subjects during the study. We observe the safety and health economic indicators of Acupuncture treatment, so as to improve the overall efficacy of TCM Combined Application in assisted reproductive technology in the future.

Condition or disease Intervention/treatment Phase
Acupuncture Female Infertility Other: Acupuncture Other: Western medicine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study on the Short-term Intervention of Acupuncture in the Freeze-all IVF Cycle to Improve Pregnancy Rate
Estimated Study Start Date : June 30, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
Drug Information available for: Cetrorelix

Arm Intervention/treatment
Experimental: Acupuncture treatment group
Method: Acupuncture at Zhongwan、Qihai、Guanyuan、Zhongji、Guilai、Shenshu、Ciliao、Xuehai、Sanyinjiao、Taixi. The acupuncture treatment starts on the 5th day of the menstrual cycle and lasts to the days before IVF-ET
Other: Acupuncture
The Acupuncture intervention(Zhongwan、Qihai、Guanyuan、Zhongji、Guilai、Shenshu、Ciliao、Xuehai、Sanyinjiao、Taixi.) will start on the 5th day of menstruation cycle, which will be carried out 1 time per day, at least 5 times a week, lasts for 10-15days. All operations were performed by experienced acupuncturists. After ET, both the control group and the treatment group will be treated with conventionally with no TCM intervention.
Other Name: conventional western medicine(Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection )

Active Comparator: Western medicine group
The western medicine group will be treated with conventional western medicine
Other: Western medicine
Western medicine

Primary Outcome Measures :
  1. Clinical pregnancy rate (%) [ Time Frame: up to 6 weeks from enrollment ]
    Follow up by telephone calls 14days after the IVF-ET

Secondary Outcome Measures :
  1. Concentration of β-human Choriogonadotropin(β-HCG) [ Time Frame: up to 6 weeks from enrollment ]
    Obtained by blood sampling 14 days after the proposed IVF-ET

Other Outcome Measures:
  1. Changes from Baseline concentration of Self rating Anxiety Scale (SAS) [ Time Frame: The 5th day of menstruation、 Baseline the proposed IVF-ET、14 days after the IVF-ET ]
    They were completed on the 5th day of menstruation, before transplantation and the 14th day after transplantation.The score of 20 items is added to get the rough score (x), and after the formula is converted, that is, the whole part is taken after multiplying the rough score by 1.25, and then the standard score (y) will be obtained.According to the results of Chinese norm, the cut-off value of SAS standard deviation was 50 points, of which 50-59 points were mild anxiety, 60-69 points were moderate anxiety, and more than 69 points were severe anxiety.

  2. Changes from Baseline concentration of Self rating Depression Scale (SDS) [ Time Frame: The 5th day of menstruation、 Baseline the proposed IVF-ET、14 days after the IVF-ET ]
    They were completed on the 5th day of menstruation, before transplantation and the 14th day after transplantation.The normal upper limit of SDS gross score is 41, and the lower the score, the better the state. The standard is divided into the integral part of the total rough score multiplied by 1.25. In China, SDS score ≥ 50 is regarded as depressive symptom.Severity of depression = cumulative score of each item / 80. Results: no depression was found in patients below 0.5; 5-0. 59 for mild to mild depression; 6-0. 69, moderate to severe; More than 0.7 was severe depression.

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Meet the diagnostic criteria for infertility.
  2. Meet the criteria for identifying kidney deficiency in TCM.
  3. Patients who Planning to undergo IVF-ET for pregnancy in our center, Age ≤40 years and ≥25 years.
  4. Previous embryo transfer failure ≥ 2 times.
  5. Menstrual cycle is basically normal, and normal ovulation has been monitored in the past.
  6. There were more than 1 blastocyst /more than 2 high-quality embryos with more than 6 cells on day 3/more than 2 high-quality embryos with more than 4 cells on day 2.
  7. Consent to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

  1. Patients with endometritis, acute pelvic inflammatory disease, mycotic vaginitis, bacterial vaginitis, adnexitis or other systemic infections.
  2. It has been confirmed that there are obvious and serious other organic lesions in the reproductive organs.
  3. Patients with allergic constitution
  4. Infertility caused by genetic factors
  5. Patients with serious primary diseases such as cardio cerebrovascular, kidney, liver and hematopoietic system and psychosis
  6. A person who is unable to cooperate (such as a combination of neurological or mental illness, or a reluctance to cooperate)
  7. The endometrial thickness on the day of hCG was less than 6 mm or the endometrial morphology on the day of hCG was type C
  8. Those who did not agree to participate in the study
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Responsible Party: Peking University Third Hospital Identifier: NCT04931355    
Other Study ID Numbers: IRB00006761-M2020443
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
Traditional chinese medicine
freeze-all IVF cycle
Embryo Transfer
Additional relevant MeSH terms:
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Infertility, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Hormone Antagonists