Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03627533
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
Dr Cipto Mangunkusumo General Hospital
Information provided by (Responsible Party):
nadia oktari, 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

Condition or disease Intervention/treatment Phase
Acupuncture in Vitro Fertilization BCL2 Gene mRNA Overexpression Oocyte Maturation Procedure: Electroacupuncture Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: electroacupuncture 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 : September 17, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627533


Locations
Layout table for location information
Indonesia
Indonesian University
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Dr Cipto Mangunkusumo General Hospital
Investigators
Layout table for investigator information
Study Chair: Christina Simadibrata, MD Medical Acupuncture of Indonesian University

Layout table for additonal information
Responsible Party: nadia oktari, principal investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03627533     History of Changes
Other Study ID Numbers: Medical Acupuncture
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No