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

Not Applicable

Recruiting

• Conditions: Repeated Implantation Failure
• Interventions: Device: acupuncture and IVF; Device: sham acupuncture and IVF

• Registration Number: NCT04533295
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-11
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 514

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture and IVF	acupuncture and IVF	Acupuncture and IVF
Sham acupuncture and IVF	sham acupuncture and IVF	Sham acupuncture and IVF

Primary Outcome Measures

Name	Time	Method
CPR	1 month after ET	Clinical pregnancy rate

Secondary Outcome Measures

Name	Time	Method
LBR	10 month after ET	Live birth rate
Questionnaire score	one year	Questionnaire score
OPR	3 month after ET	ongoing pregnancy rate
Biochemical indexes	one year	Biochemical indexes

Trial Locations

Locations (1)

Tongji Hospital,Tongji medical college,HUST; 🇨🇳 Wuhan, Hubei, China