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

Not Applicable

Completed

• Conditions: Poor Ovarian Response
• Interventions: Other: TEAS

• Registration Number: NCT03994614
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

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.

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-21
• Study Start: 2020-01-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the TEAS intervention group	TEAS	Patients in this group will be given TEAS treatment for 12 weeks prior to COS.

Primary Outcome Measures

Name	Time	Method
The number of MII eggs	one day after oocyte pickup	The number of MII eggs obtained in the COS cycle

Secondary Outcome Measures

Name	Time	Method
cleavage rate	cleavage rate calculated on 2 days after oocyte pickup	cleavage rate
Basic Follicle stimulating hormone （FSH） value	On Day two of menstruation	Basic FSH value in mIU/ml
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
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
early abortion rate	early abortion rate calculated on 12th week of pregnancy	early abortion rate
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
Basic Luteinizing hormone （LH） value	On Day two of menstruation	Basic LH in mIU/ml

Trial Locations

Locations (1)

Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China