the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of Oocyte on Poor Ovarian Response(POR)

Study Overview
=================
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.

Official Title
-----------------
The Clinical Trial of the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of the Oocyte on Poor Ovarian Response

Conditions
-----------------
Poor Ovarian Response

Intervention / Treatment
-----------------
* Other: TEAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The poor ovarian response patients compliance with Bologna consensus Age：20-45 year Women undergoing IVF-ET because of infertility for more than one year. Exclusion Criteria: 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) Complicated with other medical diseases（Hypertension, diabetes, psychosis, hereditary diseases）

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the TEAS intervention group<br>Patients in this group will be given TEAS treatment for 12 weeks prior to COS. | Other: TEAS<br>* 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).<br>|
| No Intervention: No intervention group<br>Patients in this group will not be given any interventions for 12 weeks prior to COS. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of MII eggs | The number of MII eggs obtained in the COS cycle | one day after oocyte pickup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basic Follicle stimulating hormone （FSH） value | Basic FSH value in mIU/ml | On Day two of menstruation | 
| Basic Luteinizing hormone （LH） value | Basic LH in mIU/ml | On Day two of menstruation | 
| Basic estrodiol value | Basic estrodiol in pg/ml | On Day two of menstruation | 
| Serum AMH value | Serum AMH in ng/ml | On Day two of menstruation | 
| antral follicle count | antral follicle count | antral follicle count On Day two of menstruation | 
| fertilization rate | fertilization rate | fertilization rate calculated on 1 day after oocyte pickup | 
| cleavage rate | cleavage rate | cleavage rate calculated on 2 days after oocyte pickup | 
| the number of Day 3 embryos | the number of Day 3 embryos | the number of Day 3 embryos calculated on 3 days after oocyte pickup | 
| clinical pregnancy rate | clinical pregnancy rate | clinical pregnancy rate calculated on the 6th gestational week | 
| early abortion rate | early abortion rate | early abortion rate calculated on 12th week of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcutaneous electrical acupoint stimulation, quality of oocyte, ovarian reserve, poor ovarian response, in vitro fertilization-embryo transfer