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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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. 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.

Conditions

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Acupuncture Quality of Life Infertility Stress Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In vitro fertilization patients will be randomized into two groups: treatment group (with complementary acupuncture) and control group (without complementary acupuncture).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group.

Questionnaires

Intervention Type OTHER

Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)

Control

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

Group Type ACTIVE_COMPARATOR

Questionnaires

Intervention Type OTHER

Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)

Interventions

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Acupuncture

Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group.

Intervention Type OTHER

Questionnaires

Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No