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

Federal University of Minas Gerais

Status: Unknown

Conditions: Infertility; Quality of Life; Acupuncture; Anxiety; Stress

Treatments: Other: Questionnaires; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03142490

60852116.2.0000.5149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Treatment

Experimental group

Description:

In vitro fertilization patients submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires.

Treatment:

Other: Acupuncture

Other: Questionnaires

Control

Active Comparator group

Description:

In vitro fertilization patients not submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires.

Treatment:

Other: Questionnaires