The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF

Repeated Implantation Failure Clinical Trial

Official title:

The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With Recurrent Implantation Failure: a Multi-center Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533295
• Other study ID #: 2019CR110
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Repeated Implantation Failure

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