- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04931355
Acupuncture in the Freeze-all IVF Cycle
A Randomized Controlled Study on the Short-term Intervention of Acupuncture in the Freeze-all IVF Cycle to Improve Pregnancy Rate
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: xiyan xin, associate chief physician
- Phone Number: +86 01082264623
- Email: frw9606@163.com
Study Contact Backup
- Name: ruiwen Fan
- Phone Number: +86 01082264623
- Email: frw9606@163.com
Study Locations
-
-
-
Beijing, China, China, 100029
- Recruiting
- Peking University Third Hospital
-
Contact:
- xiyan C xin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meet the diagnostic criteria for infertility.
- Meet the criteria for identifying kidney deficiency in TCM.
- Patients who Planning to undergo IVF-ET for pregnancy in our center, Age ≤40 years and ≥25 years.
- Previous embryo transfer failure ≥ 2 times.
- Menstrual cycle is basically normal, and normal ovulation has been monitored in the past.
- 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.
- Consent to participate in this clinical trial and sign an informed consent form.
Exclusion Criteria:
- Patients with endometritis, acute pelvic inflammatory disease, mycotic vaginitis, bacterial vaginitis, adnexitis or other systemic infections.
- It has been confirmed that there are obvious and serious other organic lesions in the reproductive organs.
- Patients with allergic constitution
- Infertility caused by genetic factors
- Patients with serious primary diseases such as cardio cerebrovascular, kidney, liver and hematopoietic system and psychosis
- A person who is unable to cooperate (such as a combination of neurological or mental illness, or a reluctance to cooperate)
- 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
- Those who did not agree to participate in the study
Study Plan
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Infertility
- Infertility, Female
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Cetrorelix
Other Study ID Numbers
- IRB00006761-M2020443
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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