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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 18, 2021
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedMay 31, 2023
January 1, 2023
1.6 years
June 15, 2021
May 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate (%)
Follow up by telephone calls 14days after the IVF-ET
up to 6 weeks from enrollment
Secondary Outcomes (1)
Concentration of β-human Choriogonadotropin(β-HCG)
up to 6 weeks from enrollment
Other Outcomes (2)
Changes from Baseline concentration of Self rating Anxiety Scale (SAS)
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)
The 5th day of menstruation、 Baseline the proposed IVF-ET、14 days after the IVF-ET
Study Arms (2)
Acupuncture treatment group
EXPERIMENTALMethod: 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
Western medicine group
ACTIVE COMPARATORThe western medicine group will be treated with conventional western medicine
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, China, 100029, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2021
First Posted
June 18, 2021
Study Start
June 1, 2023
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
May 31, 2023
Record last verified: 2023-01