AcupunctureNCT03142490
Acupuncture as a Complementary Therapy for in Vitro Fertilization Patients: a Randomized Controlled Trial
A study testing Acupuncture and Questionnaires in people with Acupuncture and Quality of Life, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Acupuncture, Quality of Life, Infertility
- What is being tested?
- Acupuncture and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- history of previous contact with the acupuncture technique
- severe neurological or psychiatric disorders that make it impossible to participate in the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
Rubens Tavares, MD, PhD, +5531 3409 9485, rubens.ufmg@gmail.com
Cybelle Costa, MD, +5531 3409 9485, cmvcosta@yahoo.com.br
About this study
Official title: Acupuncture as a Complementary Therapy for Infertile Patients on Treatment With in Vitro Fertilization: a Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Acupuncture, Quality of Life, Infertility, Stress, Anxiety
- Being tested
- Acupuncture, Questionnaires
- Keywords
- Acupuncture, Infertility, In vitro fertilization, Quality of life, Stress, Anxiety
- Medical subject headings
- Infertility, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group.
QuestionnairesOther
Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | In vitro fertilization patients submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires. Receives: Other: Acupuncture; Other: 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life evaluation by the WHOQOL-Bref questionnaire
Measured: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Secondary outcomes (4)
Quality of life 2
Quality of life evaluation by the SF-36 questionnaire
Measured: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Stress
Stress evaluation by the DASS 21 questionnaire
Measured: 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
Measured: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Quality of life 3
Quality of life evaluation by the FERTIQOL questionnaire
Measured: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Dec 2016
- Primary completion30 Jun 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Lene Carvalho Tavares, Federal University of Minas Gerais
- Investigators
- Rubens Tavares, MD, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142490
- Sponsor's protocol ID
- 60852116.2.0000.5149
- Status last verified
- May 2017
- First submitted
- 2 May 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as a Complementary Therapy for Infertile Patients on Treatment With in Vitro Fertilization: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03142490
- Acronym / sponsor ID
- 60852116.2.0000.5149
- Conditions
- Acupuncture, Quality of Life, Infertility, Stress, Anxiety
- Keywords
- Acupuncture, Infertility, In vitro fertilization, Quality of life, Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In vitro fertilization patients will be randomized into two groups: treatment group (with complementary acupuncture) and control group (without complementary acupuncture).
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Acupuncture, Other: QuestionnairesIn vitro fertilization patients submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires. |
| Control | Active comparator | Other: QuestionnairesIn vitro fertilization patients not submitted to acupuncture as a complementary therapy. Patients in both groups will be evaluated by 4 different questionnaires. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- history of previous contact with the acupuncture technique
- severe neurological or psychiatric disorders that make it impossible to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group. | Other | Treatment |
| QuestionnairesPatients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks) | Other | Control, Treatment |
Primary outcome
Quality of life
Time frame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Quality of life evaluation by the WHOQOL-Bref questionnaire
4 secondary outcomes
Quality of life 2
Time frame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Stress
Time frame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Pregnancy rate
Time frame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Quality of life 3
Time frame: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubens Tavares, MD, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Questionnaires in people with Acupuncture and Quality of Life, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubens L Tavares, MD, PhD (+5531 3409 9485, rubens.ufmg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: after 8 acupuncture sessions (up to 12 weeks of follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.