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

Not Applicable

• Conditions: Acupuncture; Anxiety; Infertility; Quality of Life; Stress
• Interventions: Other: Questionnaires; Other: Acupuncture

• Registration Number: NCT03142490
• Lead Sponsor: Federal University of Minas Gerais

Brief 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.

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 Timeline

• Study Start: 2016-12-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-03
• Last Update Submitted: 2017-05-03
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Questionnaires	In vitro fertilization patients not submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires.
Treatment	Acupuncture	In vitro fertilization patients submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires.
Treatment	Questionnaires	In vitro fertilization patients submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires.

Primary Outcome Measures

Name	Time	Method
Quality of life	after 8 acupuncture sessions (up to 12 weeks of follow-up)	Quality of life evaluation by the WHOQOL-Bref questionnaire

Secondary Outcome Measures

Name	Time	Method
Quality of life 2	after 8 acupuncture sessions (up to 12 weeks of follow-up)	Quality of life evaluation by the SF-36 questionnaire
Stress	after 8 acupuncture sessions (up to 12 weeks of follow-up)	Stress evaluation by the DASS 21 questionnaire
Pregnancy rate	after 8 acupuncture sessions (up to 12 weeks of follow-up)	To compare the pregnancy rates from infertile patient records between both groups
Quality of life 3	after 8 acupuncture sessions (up to 12 weeks of follow-up)	Quality of life evaluation by the FERTIQOL questionnaire

Trial Locations

Locations (1)

Federal University of Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil