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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT03627533
Collaborator
Dr Cipto Mangunkusumo General Hospital (Other)
24
Enrollment
1
Location
2
Arms
2.4
Actual Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Electroacupuncture
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
electroacupuncture versus sham electroacupunctureelectroacupuncture versus sham electroacupuncture
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF
Actual Study Start Date :
Sep 17, 2018
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Nov 30, 2018

Arms and Interventions

Arm Intervention/Treatment
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
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.
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
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 39 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indonesian University Jakarta Pusat DKI Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University
  • Dr Cipto Mangunkusumo General Hospital

Investigators

  • Study Chair: Christina Simadibrata, MD, Medical Acupuncture of Indonesian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
nadia oktari, principal investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT03627533
Other Study ID Numbers:
  • Medical Acupuncture
First Posted:
Aug 13, 2018
Last Update Posted:
Mar 27, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 27, 2019