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

Poor Ovarian Response Clinical Trial

— POR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994614
• Other study ID #: JIAI 2019-4
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Poor Ovarian Response

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