Clinical trial NCT04533295: The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF
Official title: The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With Recurrent Implantation Failure: a Multi-center Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Repeated Implantation Failure
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 514
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: CPR
timeFrame: 1 month after ET
Secondary outcomes:
measure: OPR
timeFrame: 3 month after ET
measure: LBR
timeFrame: 10 month after ET
measure: Biochemical indexes
timeFrame: one year
measure: Questionnaire score
timeFrame: one year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital,Tongji medical college,HUST
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Minming Zhang, professor
role: PRINCIPAL_INVESTIGATOR
References: