World Health Organization site
Skip Navigation Links

Main
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-59f4yr
Date of registration: 04/01/2012
Primary sponsor: Serviço de Reprodução Humana - Faculdade de Medicina do ABC - Brazil
Public title: Effect of acupuncture on anxiety in infertility women
Scientific title: Effect of acupuncture on anxiety in women undergoing to in vitro fertilization
Date of first enrolment: 01/04/2010
Target sample size: 43
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-59f4yr/
Study type: 
Study design:  Clinical trial, randomized, one blinded, of parallel arms.  
Countries of recruitment
Brazil
Contacts
Name: Daniela  Isoyama
Address:  Av. Príncipe de Gales, 821 09060-650 Santo André Brazil
Telephone: 55 11 87810910
Email: daniela.isoyama@gmail.com
Affiliation:  Serviço de Reprodução Humana - Faculdade de Medicina do ABC
Name: Daniela  Isoyama
Address:  Av. Príncipe de Gales, 821 09060-650 Santo André Brazil
Telephone: 55 11 87810910
Email: daniela.isoyama@gmail.com
Affiliation:  Serviço de Reprodução Humana - Faculdade de Medicina do ABC
Key inclusion & exclusion criteria
Inclusion criteria: Women newer than 45 years, without previous psychiatric disorders, without use of antidepressants and / or anxiolytics and without use of acupuncture before.
Exclusion criteria: Women older than 45 years, previous psychiatric disorders, use of antidepressants and / or anxiolytics and use of acupuncture before.

Age minimum: 20Y
Age maximum: 45Y
Gender: F
Health Condition(s) or Problem(s) studied
Anxiety in infertility women undergoing to in vitro fertilization.
C13.351.500.365.700
F01.470.132
N00-N99
Intervention(s)
The patients were randomly divided into two groups, the group that received traditional acupuncture treatment during the stages of IVF (Test Group), composed of 22 patients, and the control group, composed of 21 patients, and needles were inserted in areas not corresponding to points of Acupuncture.

For each patient was performed a total of four sessions at weekly intervals (period which comprised the whole IVF process, from ovulation induction to the result of ?HCG). All sessions, both traditional acupuncture and placebo were performed by the same professional acupuncturist.
For the Test group were chosen points in the forearm, chest, face and apex of the head. These regions correspond to C7 and CS6 points on forearm (bilaterally), VC17 on chest, M-CP-3 on the face and VG20 at the apex of head.8, 9
In the Control group the same number of needles was placed in the same regions, but at a distance of approximately 1.2 cm, in regions certainly do not correspondent to known acupuncture points.
It was used in all cases and points Dong Bang® 25x40mm Korean needle with stainless steel spiral cord.
After the four weekly sessions all patients returned to the researcher for reapplication of the Anxiety assessment questionnaire and final evaluation
Primary Outcome(s)
The primary endpoint was reduction of at least 30% score on the Hamilton scale when assessed after treatment.
Secondary Outcome(s)
To assess whether the reduction of anxiety reflected in an increase in pregnancy rate.
Secondary ID(s)
073/2009
Source(s) of Monetary Support
Serviço de Reprodução Humana - Faculdade de Medicina do ABC - Brazil
Secondary Sponsor(s)
Serviço de Reprodução Humana - Faculdade de Medicina do ABC - Brazil
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history