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

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Infertility; Stress; Anxiety; Acupuncture
• Intervention / Treatment: Other: Acupuncture; Other: Questionnaires

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Recruiting
      • Federal University of Minas Gerais
      • Contact: Rubens Tavares, MD, PhD; Phone Number: +5531 3409 9485; Email: rubens.ufmg@gmail.com
      • Contact: Cybelle Costa, MD; Phone Number: +5531 3409 9485; Email: cmvcosta@yahoo.com.br
      • Sub-Investigator: Victor H Melo, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; In vitro fertilization patients submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires.	Other: Acupuncture; Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group.; Other: Questionnaires; Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)
Active Comparator: Control; In vitro fertilization patients not submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires.	Other: Questionnaires; Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life evaluation by the WHOQOL-Bref questionnaire	after 8 acupuncture sessions (up to 12 weeks of follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life 2	Quality of life evaluation by the SF-36 questionnaire	after 8 acupuncture sessions (up to 12 weeks of follow-up)
Stress	Stress evaluation by the DASS 21 questionnaire	after 8 acupuncture sessions (up to 12 weeks of follow-up)
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)
Quality of life 3	Quality of life evaluation by the FERTIQOL questionnaire	after 8 acupuncture sessions (up to 12 weeks of follow-up)

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Anxiety; Stress; Infertility; Acupuncture; Quality of life; In vitro fertilization
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 60852116.2.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No