Clinical trial NCT03994614: the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of Oocyte on Poor Ovarian Response(POR)
Official title: The Clinical Trial of the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of the Oocyte on Poor Ovarian Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Ovarian Response
Keywords: transcutaneous electrical acupoint stimulation
quality of oocyte
ovarian reserve
poor ovarian response
in vitro fertilization-embryo transfer
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 92
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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）

Primary outcomes:
measure: The number of MII eggs
timeFrame: one day after oocyte pickup
Secondary outcomes:
measure: Basic Follicle stimulating hormone （FSH） value
timeFrame: On Day two of menstruation
measure: Basic Luteinizing hormone （LH） value
timeFrame: On Day two of menstruation
measure: Basic estrodiol value
timeFrame: On Day two of menstruation
measure: Serum AMH value
timeFrame: On Day two of menstruation
measure: antral follicle count
timeFrame: antral follicle count On Day two of menstruation
measure: fertilization rate
timeFrame: fertilization rate calculated on 1 day after oocyte pickup
measure: cleavage rate
timeFrame: cleavage rate calculated on 2 days after oocyte pickup
measure: the number of Day 3 embryos
timeFrame: the number of Day 3 embryos calculated on 3 days after oocyte pickup
measure: clinical pregnancy rate
timeFrame: clinical pregnancy rate calculated on the 6th gestational week
measure: early abortion rate
timeFrame: early abortion rate calculated on 12th week of pregnancy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Wenbi Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References: