Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian function. In this trial, we hypothesize that electro-acupuncture is efficient for the ovarian function and the following outcome of IVF-ET in DOR patients.
First, patients will be recruited according to the inclusion criteria and exclusion criteria. Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life) will be taken. Third, each patient will receive 24 sessions of acupuncture in 2-3 months, twice or three times a week. Last, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
338
For treatment group, two groups of acupoints will be used alternatively. The first group consists of some acupoints. The patients will be asked to stay in supine position. Disposable sterilized needles (Size: 0.25\*40/50 mm) will be inserted into a depth of 15\~35 mm and stimulated manually to evoke needle sensation. And then some acupoints will be thereafter connected to electrical stimulators and stimulated with low-frequency and the maximum tolerated intensity of the patients. The other needles without electrical stimulators will be manually stimulated to evoke "Deqi" every 10 minutes. The second group consists of other acupoints. Patients will be asked to stay in prone position. The stimulation will be in the same way as the first group.
For control group, four pseudo-acupoints are used, with two points on each shoulder and the two on each upper arm, which are not located on any meridians. The patients will be asked to stay in supine position and keep the whole body relaxed and comfortable. Disposable sterilized needles (Size: 0.18\*25 mm) will be inserted superficially to a depth of \< 5 mm without any manual stimulus and the needle sensation ("Deqi" in TCM) should not be evoked. Electrodes are connected to the needles, but the stimulators should be turned on at an intensity of zero. Each intervention lasts for 30 minutes.
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGAssessing the change of ovarian reserve function
Assessing patients' ovarian reserve function before and after electro-acupuncture intervention, including: (1) The serum AMH, inhibin, and FSH and E2 levels on the third day of menstruation;(2) AFC.
Time frame: 0 week and up to 4 weeks
Clinical pregnancy rate
the clinical pregnancy rate per cycle of IVF-ET after electro-acupuncture.
Time frame: through study completion, an average of 1 year
Outcomes of IVF
1. Gn dosage(U/d) and usage days; 2. E2 level(pg/ml) and endometrial thickness(mm) on human chorionic gonadotropin (HCG) day; 3. number of oocytes; 4. MII oocytes; 5. normal fertility rate; 6. the number of available embryos; 7. number of high-quality embryos; 8. cycle cancellation rate (including cycle cancellation rate caused by various reasons); 9. implantation rate: including fresh periodic implantation rate, per cycle implantation rate and cumulative implantation rate; 10. fresh cycle clinical pregnancy rate and cycle cumulative clinical pregnancy rate; 11. early, mid and late pregnancy abortion rate; 12. risk of ovarian hypertrophy and incidence of obstetric complications; 13. FSH(mIU/ml), LH(mIU/ml), E2(pg/ml) and AMH(ng/ml) in follicular fluid; Oxidative stress related indicators such as reactive oxygen species (ROS), superoxide dismutase (SOD) level, etc.; 14. live rate: including fresh cycle live rate, cycle live rate and cumulative live rate.
Time frame: through study completion, an average of 1 year
Blood biochemical index examination
Testing the levels of blood corticotrophin-releasing hormone (CRH), norepinephrine, adrenaline, 5-hydroxytryptamine, beta-aminobutyric acid (GABA), dopamine (DA) and neuro-endorphin of the patients before and after treatment.
Time frame: 0 week and up to 12 weeks
Questionnaires
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Evaluation of anxiety, depression, quality of life and sleep state is performed before and after treatment. 1. Baker anxiety self-rating scale (BAI) and baker depression self-rating scale (BDI-Ⅱ) : higher score indicates higher degree of depression or anxiety \[12-13\]. 2. Zung anxiety self-rating scale (Zung-SAS), Zung depression self-rating scale (Zung-SDS) \[14-15\]. 3. Quality of life measurement (QOL): Quality of life will be assessed by SF-36 and Chinese quality of life scale (CHQOL). 4. Self-Rating Scale of Sleep (SRSS), sleep dysfunction rating scale (SDRS), Pittsburgh sleep quality index (PSQI).
Time frame: 0 week and up to 4 weeks
Follow-up detection
Pregnancy patients will be followed up to the end of pregnancy. Adverse pregnancy outcomes and live birth rates will be recorded. Non-pregnant patients will be followed up for 1 year after treatment, testing the ovarian reserve function, follow-up treatment and pregnancy status of the patients within 1 year.
Time frame: through study completion, an average of 1 year