NCT03142490

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

May 2, 2017

Last Update Submit

May 3, 2017

Conditions

AcupunctureQuality of LifeInfertilityStressAnxiety

Keywords

AcupunctureInfertilityIn vitro fertilizationQuality of lifeStressAnxiety

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Quality of life evaluation by the WHOQOL-Bref questionnaire

    after 8 acupuncture sessions (up to 12 weeks of follow-up)

Secondary Outcomes (4)

  • Quality of life 2

    after 8 acupuncture sessions (up to 12 weeks of follow-up)

  • Stress

    after 8 acupuncture sessions (up to 12 weeks of follow-up)

  • Pregnancy rate

    after 8 acupuncture sessions (up to 12 weeks of follow-up)

  • Quality of life 3

    after 8 acupuncture sessions (up to 12 weeks of follow-up)

Study Arms (2)

Treatment

EXPERIMENTAL

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

Other: AcupunctureOther: 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.

Other: Questionnaires

Interventions

AcupunctureOTHER

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

Treatment
QuestionnairesOTHER

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

ControlTreatment

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsparticipant eligibility is based on self-representation
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • history of previous contact with the acupuncture technique
  • severe neurological or psychiatric disorders that make it impossible to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

MeSH Terms

Conditions

InfertilityAnxiety Disorders

Interventions

Acupuncture TherapySurveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rubens Tavares, MD, PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubens L Tavares, MD, PhD

CONTACT

+5531 3409 9485rubens.ufmg@gmail.com

Victor H Melo, MD, PhD

CONTACT

5531-3409-4592victormelo2401@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In vitro fertilization patients will be randomized into two groups: treatment group (with complementary acupuncture) and control group (without complementary acupuncture).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 5, 2017

Study Start

December 1, 2016

Primary Completion

June 30, 2018

Study Completion

December 31, 2018

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)