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

Study Overview
=================
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.

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

Conditions
-----------------
Stress, Anxiety, Acupuncture, Quality of Life, Infertility

Intervention / Treatment
-----------------
* Other: Acupuncture
* Other: Questionnaires


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In vitro fertilization patients will be randomized into two groups: treatment group (with complementary acupuncture) and control group (without complementary acupuncture).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>In vitro fertilization patients submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires. | Other: Acupuncture<br>* Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group.<br>Other: Questionnaires<br>* Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)<br>|
| Active Comparator: Control<br>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<br>* Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Acupuncture, Infertility, In vitro fertilization, Quality of life, Stress