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

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

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.

Study Overview

• Status: Completed
• Conditions: Poor Ovarian Response
• Intervention / Treatment: Other: TEAS

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the TEAS intervention group; Patients in this group will be given TEAS treatment for 12 weeks prior to COS.	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).
No Intervention: No intervention group; 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

Collaborators and Investigators

• Sponsor: ShangHai Ji Ai Genetics & IVF Institute
• Investigators: Principal Investigator: Wenbi Zhang, doctor, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: transcutaneous electrical acupoint stimulation; ovarian reserve; poor ovarian response; in vitro fertilization-embryo transfer; quality of oocyte
• Other Study ID Numbers: JIAI 2019-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No