Poor Ovarian Response
Conditions
Keywords
transcutaneous electrical acupoint stimulation, quality of oocyte, ovarian reserve, poor ovarian response, in vitro fertilization-embryo transfer
Brief summary
Patients in experimental group will be given transcutaneous electrical acupoint stimulation (TEAS) treatment for 12 weeks prior to controlled ovarian stimulation (COS).The patients will be given three times acupuncture every week except menstruation.Patients in no intervention group will not be given any interventions for 12 weeks prior to COS. The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes.
Detailed description
The patients will be randomly recruited into two groups. Patients in experimental group will be given TEAS treatment for 12 weeks prior to COS.The patients will be given three times acupuncture every week except menstruation. One treatment lasts for 30 minutes. The acupoints used for the TEAS treatment included head acupoint Baihui(DU20), abdominal acupoint Zhongji (RN3), Guanyuan (RN4), Zigong(EX-CA1), leg acupoint Sanyinjiao(SP6), waist acupoint Shenyu (BL23) and Guanyuanyu(BL26). Patients in no intervention group will not be given any intervention for 12 weeks prior to COS. When at least one dominant follicle is greater than 18 mm then injection a GnRH agonist (Triptorelin, Ferring, Switzerland) 0.2mg. 36 hours later transvaginal oocyte retrieval will be taken. After 3 hours of incubation, each egg will be transferred with a density of about 100,000/mllive sperm. The fresh embryo transfer is performed 72 hours after embryo culture in vitro. The whole embryos will be frozen. The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes,including basic endocrine, serum Anti-Mullerian Hormone （AMH）, antral follicle counts, fertilization rate, cleavage rate, number of D3 embryos, the clinical pregnancy rate and early abortion rate.
Interventions
OTHERTEAS
Patients in the experimental group will be given TEAS treatment for 12 weeks prior to COS. The patients will be given three times acupuncture every week except menstruation. The acupuncture acupoint locations are as follows: head acupoint Baihui(DU20), abdominal acupoint Zhongji (RN3), Guanyuan (RN4), Zigong(EX-CA1), leg acupoint Sanyinjiao(SP6), waist acupoint Shenyu (BL23) and Guanyuanyu(BL26).
Sponsors
ShangHai Ji Ai Genetics & IVF Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. The poor ovarian response patients compliance with Bologna consensus 2. Age：20-45 year 3. Women undergoing IVF-ET because of infertility for more than one year.
Exclusion criteria
1. Patients with genital tract malformation. Uterine malformation (single uterus, double uterus, double uterus, untreated mediastinal uterus) and other effects affecting uterine cavity disease (adenomyosis, submucosal uterine fibroids, intrauterine adhesions and scar uterus) 2. Complicated with other medical diseases（Hypertension, diabetes, psychosis, hereditary diseases）
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of MII eggs | one day after oocyte pickup | The number of MII eggs obtained in the COS cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Basic Follicle stimulating hormone （FSH） value | On Day two of menstruation | Basic FSH value in mIU/ml |
| Basic Luteinizing hormone （LH） value | On Day two of menstruation | Basic LH in mIU/ml |
| Basic estrodiol value | On Day two of menstruation | Basic estrodiol in pg/ml |
| Serum AMH value | On Day two of menstruation | Serum AMH in ng/ml |
| antral follicle count | antral follicle count On Day two of menstruation | antral follicle count |
| fertilization rate | fertilization rate calculated on 1 day after oocyte pickup | fertilization rate |
| cleavage rate | cleavage rate calculated on 2 days after oocyte pickup | cleavage rate |
| the number of Day 3 embryos | the number of Day 3 embryos calculated on 3 days after oocyte pickup | the number of Day 3 embryos |
| clinical pregnancy rate | clinical pregnancy rate calculated on the 6th gestational week | clinical pregnancy rate |
| early abortion rate | early abortion rate calculated on 12th week of pregnancy | early abortion rate |
Countries
China
Outcome results
None listed