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OpenTrials
Completed

NCT Number: NCT03627533

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

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

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Key information

Conditions

Acupuncture BCL2 Gene mRNA Overexpression In Vitro Fertilization Oocyte Maturation

Age range

30 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indonesian University

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroacupuncture

Procedure

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.

Primary outcomes

  1. Index apoptotic (Ratio Bax/Bcl-2) of granulosa cells, GDF9 and BMP15

    Time frame: "up to 1 months"

    Bax/Bcl-2 is proapoptotic protein compare to antiapoptotic protein. GDF9 and BMP15 protein expression

Secondary outcomes

  1. oocyte maturation index

    Time frame: "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

  2. Fertilization rate

    Time frame: "up to 1 months"

    fertilization rate is number of fertilized oocytes compared with all total number oocyte which taken when ovum pick-up.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Dr Cipto Mangunkusumo General Hospital

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2018
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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