Ignite Creation Date:
2024-05-06 @ 4:17 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04931355
Status:
RECRUITING
Last Update Posted:
2023-05-31
First Post:
2021-06-15
Brief Title:
Acupuncture in the Freeze-all IVF Cycle
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
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
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 anxietydepression 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
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 11 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 1-12 inches and retained for 30 minutes
QihaiRN6 The needle should be punctured for 1-12 inches and retained for 30 minutes
GuanyuanRN4 The needle should be punctured for 08-12 inches and retained for 30 minutes
ZhongjiRN3 The needle should be punctured for 08-10 inches and retained for 30 minutes
GuilaiST29 The needle should be punctured for 08-10 inches and retained for 30 minutes
ShenshuBL23 The needle should be punctured for 08-10 inches and retained for 30 minutes
CiliaoBL28 The needle should be punctured for 1-12 inches and retained for 30 minutes
XuehaiSP10 The needle should be punctured for 1-15 inches and retained for 30 minutes
ZusanliST36 The needle should be punctured for 1-15 inches and retained for 30 minutes
DijiSP8 The needle should be punctured for 1-12 inches and retained for 30 minutes
SanyinjiaoSP6 The needle should be punctured for 1-12 inches and retained for 30 minutes
TaixiKI6 The needle should be punctured for 08-12 inches and retained for 30 minutes
BaihuiDU20 The needle should be punctured for 05-10 inches and retained for 30 minutes
YintangEX-HN3 The needle should be punctured for 05-10 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 dayat 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 hCG30 IU will be considered to indicate biochemical pregnancy Ultrasound monitoring will be performed 30 days after ET to calculate the clinical pregnancy rate
The trial is designed as a randomized controlled clinical trial with two groups established by 11 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 1-12 inches and retained for 30 minutes
QihaiRN6 The needle should be punctured for 1-12 inches and retained for 30 minutes
GuanyuanRN4 The needle should be punctured for 08-12 inches and retained for 30 minutes
ZhongjiRN3 The needle should be punctured for 08-10 inches and retained for 30 minutes
GuilaiST29 The needle should be punctured for 08-10 inches and retained for 30 minutes
ShenshuBL23 The needle should be punctured for 08-10 inches and retained for 30 minutes
CiliaoBL28 The needle should be punctured for 1-12 inches and retained for 30 minutes
XuehaiSP10 The needle should be punctured for 1-15 inches and retained for 30 minutes
ZusanliST36 The needle should be punctured for 1-15 inches and retained for 30 minutes
DijiSP8 The needle should be punctured for 1-12 inches and retained for 30 minutes
SanyinjiaoSP6 The needle should be punctured for 1-12 inches and retained for 30 minutes
TaixiKI6 The needle should be punctured for 08-12 inches and retained for 30 minutes
BaihuiDU20 The needle should be punctured for 05-10 inches and retained for 30 minutes
YintangEX-HN3 The needle should be punctured for 05-10 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 dayat 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 hCG30 IU will be considered to indicate biochemical pregnancy Ultrasound monitoring will be performed 30 days after ET to calculate the clinical pregnancy rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None