Clinical trial NCT03142490: Acupuncture as a Complementary Therapy for in Vitro Fertilization Patients: a Randomized Controlled Trial
Official title: Acupuncture as a Complementary Therapy for Infertile Patients on Treatment With in Vitro Fertilization: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Quality of Life
Infertility
Stress
Anxiety
Keywords: Acupuncture
Infertility
In vitro fertilization
Quality of life
Stress
Anxiety
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In vitro fertilization patients will be randomized into two groups: treatment group (with complementary acupuncture) and control group (without complementary acupuncture).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Secondary outcomes:
measure: Quality of life 2
timeFrame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
measure: Stress
timeFrame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
measure: Pregnancy rate
timeFrame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
measure: Quality of life 3
timeFrame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Rubens Tavares, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: