Effect of Acupuncture on Anti Mullerian Hormone and Assisted Reproduction Outcome in PCOS Patients Undergoing IVF

July 19, 2019 updated by: Amina Altutunji

Acupuncture Treatment Versus Non-acupuncture During IVF

Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims to compare assisted reproduction outcome between two groups of PCOS patients underwent IVF, one group received acupuncture and other group without acupuncture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Follicular phase acupuncture applied for PCOS patients underwent IVF to evaluate the effect of acupuncture on anti-mullerian hormone (AMH) and the effect on assisted reproduction outcome. It applied at certain acupoints according to the principles of traditional Chinese medicine.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Assisted Reproduction Center, Department of Obstetrics and Gynecology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria::

  • PCOS patients with patent one or two fallopian tubes, normal uterine cavity and partners with normal semen parameters.
  • infertility
  • 20-40 years
  • IVF treatment -

Exclusion Criteria:

  • patients with disorders that have the similar clinical presentation
  • closed both tubes
  • abnormal semen parameters
  • intracytoplasmic sperm injection (ICSI)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture (Hwato®)
30-40 minutes acupuncture at certain acupoints that chosen according to traditional Chinese medicine and included LIV3,SP6,SP8,ST36,SP10,ST29,LI14,Ren 04;starting at follicular phase of the cycle till 2 days before oocyte picked up.
Device: Acupuncture(Hwato®)
acupuncture using 4cm long disposable stainless steel hair-thin needles manufactured by Suzhou medical appliance factory (China).
No Intervention: No acupuncture
No intervention was done for this group of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate.
Time Frame: 13 months
Increase in pregnancy rate
13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 15 months
Increase in ongoing pregnancy rate
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amina Altutunji

Collaborators

Huazhong University of Science and Technology

Investigators

  • Study Director: Ying Gao, Ph.D., M.D., Assisted Reproduction Center, Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MINA-1978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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