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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | In vitro fertilization patients submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires. |
|
| Control | Active Comparator | In vitro fertilization patients not submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
participant eligibility is based on self-representation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rubens L Tavares, MD, PhD | Contact | +5531 3409 9485 | rubens.ufmg@gmail.com | |
| Victor H Melo, MD, PhD | Contact | 5531-3409-4592 | victormelo2401@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rubens Tavares, MD, PhD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Minas Gerais | Recruiting | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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In vitro fertilization patients will be randomized into two groups: treatment group (with complementary acupuncture) and control group (without complementary acupuncture).
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| Questionnaires | Other | Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks) |
|
| 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) |
| D008919 |
| Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |