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CompletedNCT03627533Updated Mar 27, 2019

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

An interventional study of Electroacupuncture in Acupuncture, in Vitro Fertilization and BCL2 Gene mRNA Overexpression, sponsored by Universitas Indonesia. Completed at 1 site in Indonesia. Open to female participants aged 30 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-27.

Sponsored by Universitas Indonesia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
30 Years to 39 Years
Sex
Female
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Study 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

Read the 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

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Conditions studied

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

Lead sponsor

Universitas Indonesia is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • having skin infection at acupoint location
  • use a pacemaker
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    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.

    Procedure: Electroacupuncture

  • Sham comparator
    Sham electroacupuncture

    Sham electroacupuncture are done at same electroacupuncture point location but puncture are not done, also electro stimulator are turned off.

    Procedure: Electroacupuncture

Interventions

  • ProcedureElectroacupuncture

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: "up to 1 months"

Secondary outcomes

  1. 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

    Time frame: "up to 1 months"

  2. Fertilization rate

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

    Time frame: "up to 1 months"

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Study locations

1 site
  • Indonesian University
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03627533
Lead sponsor
Universitas Indonesia
Collaborators
Dr Cipto Mangunkusumo General Hospital
Responsible party
nadia oktari (principal investigator, Universitas Indonesia) — Principal investigator
First posted
Aug 13, 2018
Start date
Sep 17, 2018
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018
Last update
Mar 27, 2019

Study contacts

Christina Simadibrata, MD
study chair · Medical Acupuncture of Indonesian University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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