The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF

Acupuncture Clinical Trial

Official title:

The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627533
• Other study ID #: Medical Acupuncture
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: March 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventional studies compared electroacupuncture group versus sham electroacupuncture group to granulosa cell apoptosis index, oocyte maturation, GDF9 and BMP15 levels, and fertilization rate in in vitro fertilization program

Description:

The study was conducted at the Dr.Cipto Mangunkusumo National General Hospital, Indonesia in September - November 2018.The inclusion criteria are patients who underwent controlled ovarian stimulation with antagonist protocol, age 30-39 years, BMI <29kg / m2. Exclusion criteria were not having a skin infection at acupuncture point and not using a pacemaker. Then patients were randomly divided into two groups: electroacupuncture and sham electroacupuncture. Electroacupuncture therapy was done 6 times at: 2 times before and 4 times during controlled ovarian stimulation.Apoptotic index of granulosa cells were examined by quantitative real time PCR techniques for BAX/BCL-2 expression.Oocyte maturation and fertilization rate output parameters are examined by competent embryologists after ovum pick up while GDF9 and BMP15 levels were examined by quantitative real time PCR techniques for GDF9 and BMP15 mRNA expression

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 39 Years

Eligibility

Inclusion Criteria:

• women underwent controlled ovarian stimulation with antagonist protocol

• BMI < 29 kg/m2

• willing and sign the inform consent

• follow the research until completed

Exclusion Criteria:

• having skin infection at acupoint location

• use a pacemaker

Related Conditions & MeSH terms

• Acupuncture
• BCL2 Gene mRNA Overexpression
• in Vitro Fertilization
• Oocyte Maturation

Intervention

Procedure:
• Electroacupuncture
Electroacupuncture therapy is done at the point of CV3 Zhongji, CV4 Guanyuan, and EXCA-1 Zigong with continuous wave, 2 Hz frequency for 30 minutes. Acupuncture manuals on endocrine ear points, GV20 Baihui, ST36 Zusanli, SP6 Sanyinjiao, BL57 Chengsan and KI3 Taixi for 30 minutes.

Locations

Country	Name	City	State
Indonesia	Indonesian University	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Dr Cipto Mangunkusumo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index apoptotic (Ratio Bax/Bcl-2) of granulosa cells, GDF9 and BMP15	Bax/Bcl-2 is proapoptotic protein compare to antiapoptotic protein. GDF9 and BMP15 protein expression	"up to 1 months"
Secondary	oocyte maturation index	fertilization rate is number of fertilized oocytes compared with all total number oocyte which taken when ovum pick-up. oocyte maturation index is the number of mature oocyte (metaphase II oocyte) compare with all total number oocyte which taken when ovum pick-up	"up to 1 months"
Secondary	Fertilization rate	fertilization rate is number of fertilized oocytes compared with all total number oocyte which taken when ovum pick-up.	"up to 1 months"