Acupuncture, Anxiety, Infertility, Quality of Life, Stress
Conditions
Keywords
Acupuncture, Infertility, In vitro fertilization, Quality of life, Stress, Anxiety
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.
Interventions
OTHERAcupuncture
Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group.
OTHERQuestionnaires
Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In vitro fertilization patients will be randomized into two groups: treatment group (with complementary acupuncture) and control group (without complementary acupuncture).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | after 8 acupuncture sessions (up to 12 weeks of follow-up) | Quality of life evaluation by the WHOQOL-Bref questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Contacts
Primary ContactRubens L Tavares, MD, PhD
Backup ContactVictor H Melo, MD, PhD
Outcome results
None listed