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

NCT ID: NCT04533295

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 514 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2024-12-31

Brief 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.

Conditions

Repeated Implantation Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acupuncture and IVF

Acupuncture and IVF

Group Type: EXPERIMENTAL

acupuncture and IVF

Intervention Type: DEVICE

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 and IVF

Group Type: SHAM_COMPARATOR

sham acupuncture and IVF

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Cui Hong Zheng

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minming Zhang, professor

Role: PRINCIPAL_INVESTIGATOR

Huazhong University of Science and Technology

Locations

Tongji Hospital,Tongji medical college,HUST

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cuihong Zheng, professor

Role: CONTACT

chzheng@tjh.tjmu.edu.cn

86-27-83663275

Facility Contacts

Cuihong Zheng, professor

Role: primary

Other Identifiers

2019CR110

Identifier Type: -

Identifier Source: org_study_id