Acupuncture in the Freeze-all IVF Cycle

Acupuncture Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acupuncture
• Female Infertility
• Infertility
• Infertility, Female

• NCT number: NCT04931355
• Study type: Interventional
• Source: Peking University Third Hospital
• Contact: xiyan xin, associate chief physician
• Phone: +86 01082264623
• Email: frw9606@163.com
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Completion date: December 30, 2024