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

Not Applicable

Completed

• Conditions: in Vitro Fertilization; Acupuncture; BCL2 Gene mRNA Overexpression; Oocyte Maturation
• Interventions: Procedure: Electroacupuncture

• Registration Number: NCT03627533
• Lead Sponsor: Indonesia University

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-13
• Study Start: 2018-09-17
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	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 MA-IC3 endocrine (ear points), GV20 Baihui, ST36 Zusanli, SP6 Sanyinjiao, BL57 Chengsan and KI3 Taixi for 30 minutes.
Sham electroacupuncture	Electroacupuncture	Sham electroacupuncture are done at same electroacupuncture point location but puncture are not done, also electro stimulator are turned off.

Primary Outcome Measures

Name	Time	Method
Index apoptotic (Ratio Bax/Bcl-2) of granulosa cells, GDF9 and BMP15	"up to 1 months"	Bax/Bcl-2 is proapoptotic protein compare to antiapoptotic protein. GDF9 and BMP15 protein expression

Secondary Outcome Measures

Name	Time	Method
oocyte maturation index	"up to 1 months"	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
Fertilization rate	"up to 1 months"	fertilization rate is number of fertilized oocytes compared with all total number oocyte which taken when ovum pick-up.

Trial Locations

Locations (1)

Indonesian University; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia