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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04533295
Other study ID # 2019CR110
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 11, 2020
Est. completion date December 31, 2024

Study information

Verified date April 2021
Source Huazhong University of Science and Technology
Contact Cuihong Zheng, professor
Phone 86-27-83663275
Email chzheng@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into two groups: acupuncture +IVF group and sham acupuncture +IVF group.


Recruitment information / eligibility

Status Recruiting
Enrollment 514
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria: 1. Married women aged 25-40; 2. Repeated implantation failure for unknown reasons (after 3 or more consecutive cycles of embryo transfer, or cumulative transfer of =6 high-quality cleavage embryos or 4 high-quality blastocysts without clinical pregnancy); 3. Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (=3BB); 4. Estrogen and progesterone replacement therapy (HRT), endometrial thickness =7mm on the day of endometrial transformation. Exclusion Criteria: Patients who met any of the following conditions were not included. 1. Those who prepare for PGD; 2. Recipients of egg donors; 3. Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism); 4. patients with implantation failure due to known embryonic factors; 5. Uterine lesions that may affect implantation (including uterine malformation, uterine tuberculosis, history of intrauterine adhesions, submucosal fibroids, adenomyosis, >4cm intramural fibroids) 6. Repeated spontaneous abortion (2 or more fetal loss before 28 weeks of gestation); 7. Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months; 8. Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.; 9. Hydrosalpinx untreated; 10. BMI less than 18 and higher than 25kg/m2; 11. People with previous history of needle sickness; 12. Those who had previously participated in this study or had received acupuncture treatment in the past 3 months. 13. Any situation that researchers consider inappropriate for participating in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
acupuncture and IVF
Acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation and ending within 24 hours after embryo transfer.
sham acupuncture and IVF
Sham acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation and ending within 24 hours after embryo transfer.

Locations

Country Name City State
China Tongji Hospital,Tongji medical college,HUST Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CPR Clinical pregnancy rate 1 month after ET
Secondary OPR ongoing pregnancy rate 3 month after ET
Secondary LBR Live birth rate 10 month after ET
Secondary Biochemical indexes Biochemical indexes one year
Secondary Questionnaire score Questionnaire score one year
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