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

NCT03627533 | Completed

• 1 other identifier: Medical Acupuncture
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Acupuncture; in Vitro Fertilization; BCL2 Gene mRNA Overexpression; Oocyte Maturation

Outcome Measures

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

  "up to 1 months"

Secondary Outcomes (2)

• oocyte maturation index

  "up to 1 months"

• Fertilization rate

  "up to 1 months"

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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 electroacupuncture

SHAM COMPARATOR

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

Procedure: Electroacupuncture

Interventions

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.

Electroacupuncture; Sham electroacupuncture

Eligibility Criteria

• Age: 30 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women underwent controlled ovarian stimulation with antagonist protocol
• BMI \< 29 kg/m2
• willing and sign the inform consent
• follow the research until completed

You may not qualify if:

• having skin infection at acupoint location
• use a pacemaker

Sponsors & Collaborators

• Indonesia University: lead
• Dr Cipto Mangunkusumo General Hospital: collaborator

Study Sites (1)

Indonesian University

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Christina Simadibrata, MD

  Medical Acupuncture of Indonesian University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: electroacupuncture versus sham electroacupuncture

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 13, 2018
• Study Start: September 17, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)