Acupuncture in the Freeze-all IVF Cycle

May 28, 2023 updated by: Peking University Third Hospital

A Randomized Controlled Study on the Short-term Intervention of Acupuncture in the Freeze-all IVF Cycle to Improve Pregnancy Rate

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.

Study Overview

Status

Recruiting

Detailed Description

The study will be conducted on patients with DOR attending our reproductive medicine center for proposed IVF-ET between June 2021and December 2022.

The trial is designed as a randomized, controlled clinical trial with two groups established by 1:1 equal allocation, a treatment group with interventions using acupuncture to tonify the kidneys and regulate blood and a control group treated using conventional Western medicine.

Random numbers will be prepared by an independent third-party statistician who prepared a list of random group codes for this study. Enrolled subjects will be given a subject number during the screening process and, upon formal enrolment, will be randomly assigned to either the test or control group with a corresponding random number.

The acupoints used will be:

Zhongwan (RN12) :The needle should be punctured for 1-1.2 inches and retained for 30 minutes.

Qihai(RN6): The needle should be punctured for 1-1.2 inches and retained for 30 minutes.

Guanyuan(RN4): The needle should be punctured for 0.8-1.2 inches and retained for 30 minutes.

Zhongji(RN3): The needle should be punctured for 0.8-1.0 inches and retained for 30 minutes.

Guilai(ST29): The needle should be punctured for 0.8-1.0 inches and retained for 30 minutes.

Shenshu(BL23): The needle should be punctured for 0.8-1.0 inches and retained for 30 minutes.

Ciliao(BL28): The needle should be punctured for 1-1.2 inches and retained for 30 minutes.

Xuehai(SP10): The needle should be punctured for 1-1.5 inches and retained for 30 minutes.

Zusanli(ST36): The needle should be punctured for 1-1.5 inches and retained for 30 minutes.

Diji(SP8): The needle should be punctured for 1-1.2 inches and retained for 30 minutes.

Sanyinjiao(SP6): The needle should be punctured for 1-1.2 inches and retained for 30 minutes.

Taixi(KI6): The needle should be punctured for 0.8-1.2 inches and retained for 30 minutes.

Baihui(DU20): The needle should be punctured for 0.5-1.0 inches and retained for 30 minutes.

Yintang(EX-HN3): The needle should be punctured for 0.5-1.0 inches and retained for 30 minutes.

The Acupuncture intervention will start on the 5th day of the 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.

Serum human chorionic gonadotropin (hCG) will be measured, and an hCG>30 IU will be considered to indicate biochemical pregnancy. Ultrasound monitoring will be performed 30 days after ET to calculate the clinical pregnancy rate.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: xiyan xin, associate chief physician
  • Phone Number: +86 01082264623
  • Email: frw9606@163.com

Study Contact Backup

Study Locations

      • Beijing, China, China, 100029
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • xiyan C xin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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 Names:
  • 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
Western medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate (%)
Time Frame: up to 6 weeks from enrollment
Follow up by telephone calls 14days after the IVF-ET
up to 6 weeks from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 weeks from enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The 5th day of menstruation、 Baseline the proposed IVF-ET、14 days after the IVF-ET
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.
The 5th day of menstruation、 Baseline the proposed IVF-ET、14 days after the IVF-ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 28, 2023

Last Verified

January 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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