Acupuncture as a Complementary Therapy for in Vitro Fertilization Patients: a Randomized Controlled Trial

Anxiety Clinical Trial

Official title:

Acupuncture as a Complementary Therapy for Infertile Patients on Treatment With in Vitro Fertilization: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03142490
• Other study ID #: 60852116.2.0000.5149
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2017
• Last updated: May 3, 2017
• Start date: December 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2017
• Source: Federal University of Minas Gerais
• Contact: Rubens L Tavares, MD, PhD
• Phone: +5531 3409 9485
• Email: rubens.ufmg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label randomized controlled trial of the use of acupuncture in infertile patients receiving In Vitro Fertilization (IVF). Patients will be randomized into two groups: treatment group will receive acupuncture as a complementary approach to IVF and control group will receive the IVF treatment. Groups will be compared with the World Health Organization quality of life (WHOQOL-Bref), short-form 36 (SF-36), State Trait Anxiety Inventory (STAI) and Scope-Stress questionnaires.

Description:

This is an open-label randomized controlled trial of the use of acupuncture in infertile patients receiving In Vitro Fertilization (IVF). Patients will be randomized into two groups: treatment group will receive acupuncture as a complementary approach to IVF and control group will receive the IVF treatment. Groups will be compared with the World Health Organization quality of life (WHOQOL-Bref), short-form 36 (SF-36), State Trait Anxiety Inventory (STAI) and Scope-Stress questionnaires. In addition, data from medical records of infertile patients submitted to in vitro fertilization for treatment of infertility will be compared in the two different treatment groups (with and without acupuncture), such as the required dose of drugs for the treatment, number of ovarian follicles, number of oocytes captured, quality of oocytes, number of embryos, quality of embryos, pregnancy and abortion rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• female patient

• age over 18 years

• diagnosis of infertility with indication of IVF

• agreement accept to participate in the study

• signature of the consent form

Exclusion Criteria:

• history of previous contact with the acupuncture technique

• severe neurological or psychiatric disorders that make it impossible to participate in the study

Related Conditions & MeSH terms

• Acupuncture
• Anxiety
• Infertility
• Quality of Life
• Stress

Intervention

Other:
• Acupuncture
Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group.
• Questionnaires
Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of life evaluation by the WHOQOL-Bref questionnaire	after 8 acupuncture sessions (up to 12 weeks of follow-up)
Secondary	Quality of life 2	Quality of life evaluation by the SF-36 questionnaire	after 8 acupuncture sessions (up to 12 weeks of follow-up)
Secondary	Stress	Stress evaluation by the DASS 21 questionnaire	after 8 acupuncture sessions (up to 12 weeks of follow-up)
Secondary	Pregnancy rate	To compare the pregnancy rates from infertile patient records between both groups	after 8 acupuncture sessions (up to 12 weeks of follow-up)
Secondary	Quality of life 3	Quality of life evaluation by the FERTIQOL questionnaire	after 8 acupuncture sessions (up to 12 weeks of follow-up)