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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03994614
Other study ID # JIAI 2019-4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date May 1, 2021

Study information

Verified date March 2022
Source ShangHai Ji Ai Genetics & IVF Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date May 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
TEAS
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).

Locations

Country Name City State
China Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of MII eggs The number of MII eggs obtained in the COS cycle one day after oocyte pickup
Secondary Basic Follicle stimulating hormone (FSH) value Basic FSH value in mIU/ml On Day two of menstruation
Secondary Basic Luteinizing hormone (LH) value Basic LH in mIU/ml On Day two of menstruation
Secondary Basic estrodiol value Basic estrodiol in pg/ml On Day two of menstruation
Secondary Serum AMH value Serum AMH in ng/ml On Day two of menstruation
Secondary antral follicle count antral follicle count antral follicle count On Day two of menstruation
Secondary fertilization rate fertilization rate fertilization rate calculated on 1 day after oocyte pickup
Secondary cleavage rate cleavage rate cleavage rate calculated on 2 days after oocyte pickup
Secondary 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
Secondary clinical pregnancy rate clinical pregnancy rate clinical pregnancy rate calculated on the 6th gestational week
Secondary early abortion rate early abortion rate early abortion rate calculated on 12th week of pregnancy
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