Decreased Ovarian Reserve
Conditions
Brief summary
The randomized, placebo-controlled multicenter trial is conducted in three centers in China. After screening and obtaining the signed informed consent, the participants are randomly divided into two groups: acupuncture group and sham acupuncture group.
Interventions
DEVICEacupuncture
acupuncture
DEVICESham acupuncture
Sham acupuncture
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Infertile women older than 18 years and younger than 40 years to undergo fresh IVF or self-pregnant; 2. AMH\<1.1 ng/ml； 3. total AFC\< 7； 4. 10 U/L\<FSH\< 25IU/L,或FSH/LH\>2.6； 5. had a history of low ovarian response once, and the number of eggs obtained in IVF was less than 3 （at least two of the 2）3）4）5 ）items are required）； 6. Willing to accept randomized grouping, treatment arrangement and follow-up, and signing informed consent.
Exclusion criteria
Patients who met any of the following conditions were not included: 1. Severe abnormality of uterine cavity caused by adenomyosis, uterine fibroids, endometrial polyps, tuberculosis of the reproductive system, endometritis, abnormal endometrial thickness (HCG day of the previous IVF cycle is less than 7mm or greater than 14mm); 2. 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; 3. Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.; 4. Untreated hydrosalpinx; 5. Body mass index (BMI) higher than 28 kg/m; 6. The male or female chromosome abnormality; 7. People with previous history of acupuncture sickness; 8. Those who have previously participated in the study or are currently receiving acupuncture treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AFC | on the 3rd day of menstruation | Antral follicle count |
Secondary
| Measure | Time frame |
|---|---|
| Blood levels of FSH, LH, E2 and AMH on the 3rd day of menstruation | on the 3rd day of menstruation |
| β-HCG positive pregnancy rate | Two weeks after ET or when menstruation expired for natural pregnancy |
| Clinical pregnancy rate | 4 weeks after ET or natural pregnancy: B ultrasonography was used to observe whether there were pregnant sac and cardiac tube pulsation in uterine cavity |
| Live birth rate | Gestation greater than 24 weeks and birth as a live fetus |
Countries
China
Contacts
Primary ContactCuihong Zheng, Professor
Outcome results
None listed