search
Back to results

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

Primary Purpose

Acupuncture, Quality of Life, Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acupuncture
Questionnaires
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture focused on measuring Acupuncture, Infertility, In vitro fertilization, Quality of life, Stress, Anxiety

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Federal University of Minas GeraisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Quality of life
Quality of life evaluation by the WHOQOL-Bref questionnaire

Secondary Outcome Measures

Quality of life 2
Quality of life evaluation by the SF-36 questionnaire
Stress
Stress evaluation by the DASS 21 questionnaire
Pregnancy rate
To compare the pregnancy rates from infertile patient records between both groups
Quality of life 3
Quality of life evaluation by the FERTIQOL questionnaire

Full Information

First Posted
May 2, 2017
Last Updated
May 3, 2017
Sponsor
Federal University of Minas Gerais
search

1. Study Identification

Unique Protocol Identification Number
NCT03142490
Brief Title
Acupuncture as a Complementary Therapy for in Vitro Fertilization Patients: a Randomized Controlled Trial
Official Title
Acupuncture as a Complementary Therapy for Infertile Patients on Treatment With in Vitro Fertilization: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Quality of Life, Infertility, Stress, Anxiety
Keywords
Acupuncture, Infertility, In vitro fertilization, Quality of life, Stress, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
In vitro fertilization patients submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
In vitro fertilization patients not submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)
Primary Outcome Measure Information:
Title
Quality of life
Description
Quality of life evaluation by the WHOQOL-Bref questionnaire
Time Frame
after 8 acupuncture sessions (up to 12 weeks of follow-up)
Secondary Outcome Measure Information:
Title
Quality of life 2
Description
Quality of life evaluation by the SF-36 questionnaire
Time Frame
after 8 acupuncture sessions (up to 12 weeks of follow-up)
Title
Stress
Description
Stress evaluation by the DASS 21 questionnaire
Time Frame
after 8 acupuncture sessions (up to 12 weeks of follow-up)
Title
Pregnancy rate
Description
To compare the pregnancy rates from infertile patient records between both groups
Time Frame
after 8 acupuncture sessions (up to 12 weeks of follow-up)
Title
Quality of life 3
Description
Quality of life evaluation by the FERTIQOL questionnaire
Time Frame
after 8 acupuncture sessions (up to 12 weeks of follow-up)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
participant eligibility is based on self-representation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubens L Tavares, MD, PhD
Phone
+5531 3409 9485
Email
rubens.ufmg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Victor H Melo, MD, PhD
Phone
5531-3409-4592
Email
victormelo2401@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens Tavares, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubens Tavares, MD, PhD
Phone
+5531 3409 9485
Email
rubens.ufmg@gmail.com
First Name & Middle Initial & Last Name & Degree
Cybelle Costa, MD
Phone
+5531 3409 9485
Email
cmvcosta@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Victor H Melo, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs