COaching Lifestyle Intervention for FErtility (COLIFE)

August 6, 2021 updated by: Maritta Poyhonen-Alho, Helsinki University Central Hospital
In Finland, every third woman is overweight (BMI>25) and 11,5% obese (BMI>30). Cohort and national studies reveal that 46% of fertile-aged men have BMI≥25 and 20% BMI≥30. Overweight has negative impact on both female and male fertility and weakens markedly the results of infertility treatments. In this study, 780 infertile couples will be randomized to control group (conventional infertility treatment) and lifestyle intervention arm undergoing 4 sessions of video-mediated motivational interview, anthropometric measurements, laboratory tests and epigenetic samples. Economic evaluation of the intervention will also be performed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1560

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • infertility
  • BMI 27-34.9 kg/m2

Exclusion Criteria:

  • no mobile device available
  • evident sperm defect or ovarian tube block
  • hinder for fluent treatment schedule due to the subjec´s obstacle (inadequate language skills, major time table problems)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Conventional treatment
Active Comparator: Intervention
Motivational interview
Behavioral: Life Style
Life Style intervention including physical activity, diet, sleep and stress

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Behavior change
Time Frame: 6 months
score from 1 to 4: (smoking + daily vegetable, fruit and berry use >500g + BMI 19-27 + 150 min of moderate exercise/week) No=0, Yes=1 measured at the beginning, at 3 and 6 months
6 months
Live birth rate
Time Frame: 3 years
Number of live children born
3 years
Weight change
Time Frame: 6 months
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infertility treatments, number
Time Frame: 3 years
Number of infertility treatments needed for a live birth
3 years
Infertility treatments, mode
Time Frame: 3 years
Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI)
3 years
Miscarriage rate
Time Frame: 3 years
Number of miscarriages
3 years
Height
Time Frame: 0 months
Measured without shoes (cm)
0 months
Weight
Time Frame: 0 months
Measured without shoes and with light clothing (kg)
0 months
Weight
Time Frame: 3 months
Measured without shoes and with light clothing (kg)
3 months
Weight
Time Frame: 6 months
Measured without shoes and with light clothing (kg)
6 months
Body mass index
Time Frame: 0 months
Weight in kilograms divided by the square of height in meters
0 months
Body mass index
Time Frame: 3 months
Weight in kilograms divided by the square of height in meters
3 months
Body mass index
Time Frame: 6 months
Weight in kilograms divided by the square of height in meters
6 months
Body composition
Time Frame: 0 months
Bioimpedance method
0 months
Body composition
Time Frame: 3 months
Bioimpedance method
3 months
Body composition
Time Frame: 6 months
Bioimpedance method
6 months
Waist circumference
Time Frame: 0 months
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
0 months
Waist circumference
Time Frame: 3 months
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
3 months
Waist circumference
Time Frame: 6 months
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
6 months
Self-reported physical activity
Time Frame: 0 months
Minutes per week, International Physical Activity Questionnaire - Short Form
0 months
Self-reported physical activity
Time Frame: 6 months
Minutes per week, International Physical Activity Questionnaire - Short Form
6 months
Physical activity
Time Frame: 0 months
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
0 months
Physical activity
Time Frame: 3 months
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
3 months
Physical activity
Time Frame: 6 months
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
6 months
Maximal oxygen uptake
Time Frame: 0 months
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
0 months
Maximal oxygen uptake
Time Frame: 3 months
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
3 months
Maximal oxygen uptake
Time Frame: 6 months
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
6 months
Dietary content
Time Frame: 0 months
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
0 months
Dietary content
Time Frame: 6 months
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
6 months
Dietary patterns
Time Frame: 0 months
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
0 months
Dietary patterns
Time Frame: 6 months
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
6 months
Folate
Time Frame: 0 months
Plasma folate concentration
0 months
Folate
Time Frame: 6 months
Plasma folate concentration
6 months
Vitamin-D
Time Frame: 0 months
Plasma vitamin-D concentration
0 months
Vitamin-D
Time Frame: 6 months
Plasma vitamin-D concentration
6 months
Zinc
Time Frame: 0 months
Plasma zinc concentration
0 months
Zinc
Time Frame: 6 months
Plasma zinc concentration
6 months
Carbohydrates
Time Frame: 0 months
Amount of daily carbohydrates in diet , FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
0 months
Carbohydrates
Time Frame: 6 months
Amount of daily carbohydrates in diet, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
6 months
Protein
Time Frame: 0 months
Amount of daily proteins in diet, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
0 months
Protein
Time Frame: 6 months
Amount of daily proteins in diet, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
6 months
Alcohol
Time Frame: 0 months
Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
0 months
Alcohol
Time Frame: 6 months
Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
6 months
n-3 fatty acids
Time Frame: 0 months
Amount of daily n-3 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
0 months
n-3 fatty acids
Time Frame: 6 months
Amount of daily n-3 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
6 months
n-6 fatty acids
Time Frame: 0 months
Amount of daily n-6 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
0 months
n-6 fatty acids
Time Frame: 6 months
Amount of daily n-6 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
6 months
Saturated fatty acids
Time Frame: 0 months
Amount of daily saturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
0 months
Saturated fatty acids
Time Frame: 6 months
Amount of daily saturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
6 months
Monounsaturated fatty acids
Time Frame: 0 months
Amount of daily monounsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
0 months
Monounsaturated fatty acids
Time Frame: 6 months
Amount of daily monounsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
6 months
Polyunsaturated fatty acids
Time Frame: 0 months
Amount of daily polyunsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
0 months
Polyunsaturated fatty acids
Time Frame: 6 months
Amount of daily polyunsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
6 months
Sleep
Time Frame: 0 months
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
0 months
Sleep
Time Frame: 6 months
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
6 months
Sleep, measured
Time Frame: 0 months
Quality, sleep disruptions, total sleep duration registered by Oura ring application
0 months
Sleep, measured
Time Frame: 3 months
Quality, sleep disruptions, total sleep duration registered by Oura ring application
3 months
Sleep, measured
Time Frame: 6 months
Quality, sleep disruptions, total sleep duration registered by Oura ring application
6 months
Stress recovery
Time Frame: 0 months
Night-time heart rate variability regisered by Oura ring application
0 months
Stress recovery
Time Frame: 3 months
Night-time heart rate variability registered by Oura ring application
3 months
Stress recovery
Time Frame: 6 months
Night-time heart rate variability registered by Oura ring application
6 months
Anxiety and depression
Time Frame: 0 months
Hospital Anxiety and Depression Scale (HADS)
0 months
Anxiety and depression
Time Frame: 3 months
Hospital Anxiety and Depression Scale (HADS)
3 months
Anxiety and depression
Time Frame: 6 months
Hospital Anxiety and Depression Scale (HADS)
6 months
Fertility quality of life
Time Frame: 0 months
FertiQoL International Questionnaire
0 months
Fertility quality of life
Time Frame: 6 months
FertiQoL International Questionnaire
6 months
Depression
Time Frame: 0 months
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
0 months
Depression
Time Frame: 6 months
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
6 months
Self-determined motivation for physical activity
Time Frame: 0 months
Behavioral Regulations for Exercise Questionnaire (BREQ-3, Markland, D. & Tobin, 2004). Includes the subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation.
0 months
Self-determined motivation for physical activity
Time Frame: 6 months
Behavioral Regulations for Exercise Questionnaire (BREQ-3, Markland, D. & Tobin, 2004). Includes the subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation
6 months
Intention and action planning for physical activity; Intention to increase physical activity
Time Frame: 0 months
Three (adapted) items from the Health Action Process Approach Questionnaire, (Schwarzer R. Modeling health behaviour change: how to predict and modify the adoption and maintenance of health behaviors. Appl Psychol, 2008; 57:1-29)
0 months
Intention and action planning for physical activity; Intention to increase physical activity
Time Frame: 6 months
Three (adapted) items from the Health Action Process Approach Questionnaire (Schwarzer R. Modeling health behaviour change: how to predict and modify the adoption and maintenance of health behaviors. Appl Psychol, 2008; 57:1-29)
6 months
Self-efficacy for physical activity
Time Frame: 0 months
18-item scale developed by Albert Bandura (Bandura A. 2006). Guide for constructing self-efficacy scales. In: Pajares F, Urdan T (eds)Self-efficacy beliefs of adolescents. Information Age, Charlotte, pp 307-337)
0 months
Self-efficacy for physical activity
Time Frame: 6 months
18-item scale developed by Albert Bandura (Bandura A. 2006). Guide for constructing self-efficacy scales. In: Pajares F, Urdan T (eds)Self-efficacy beliefs of adolescents. Information Age, Charlotte, pp 307-337)
6 months
Pregnancy complications
Time Frame: 3 years
Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth)
3 years
Delivery complications
Time Frame: 3 years
Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)
3 years
Neonatal outcome
Time Frame: 3 years
Birth weight, cord pH, Apgar score
3 years
Body composition of the newborn
Time Frame: At birth
Bioimpedance method
At birth
Growth of the child
Time Frame: Up to 16 years of age
From the records of the national child care centers and schools
Up to 16 years of age
Sperm epigenetic profile
Time Frame: 0 months
Determination of heritable phenotype
0 months
Sperm epigenetic profile
Time Frame: 6 months
Determination of heritable phenotype
6 months
Transcriptome
Time Frame: 0 months
RNA-sequencing
0 months
Transcriptome
Time Frame: 6 months
RNA-sequencing
6 months
Sperm oxidative stress
Time Frame: 0 months
the Male infertility Oxidative System test (MiOXSYS)
0 months
Sperm oxidative stress
Time Frame: 6 months
the Male infertility Oxidative System test (MiOXSYS)
6 months
A cost-utility of the intervention
Time Frame: 3 years
analysis based on WHOQOL-BREF Questionnaire and FertiQoL, relating the quality-adjusted life years (QALYS) to the costs of the intervention
3 years
QALY baseline
Time Frame: 0 months
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
0 months
QALY end point
Time Frame: 6 months
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
6 months
Cost-effectiveness
Time Frame: 3 years
ICER
3 years
Static postural balance
Time Frame: 0 months
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
0 months
Static postural balance
Time Frame: 1st trimester of pregnancy
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
1st trimester of pregnancy
Static postural balance
Time Frame: 2nd trimester of pregnancy
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
2nd trimester of pregnancy
Static postural balance
Time Frame: 3rd trimester of pregnancy
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
3rd trimester of pregnancy
Static postural balance
Time Frame: 3 months postpartum
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
3 months postpartum
Perception of stress
Time Frame: 0 months
Perceived Stress Scale by Sheldon Cohen
0 months
Perception of stress
Time Frame: 3 months
Perceived Stress Scale by Sheldon Cohen
3 months
Perception of stress
Time Frame: 6 months
Perceived Stress Scale by Sheldon Cohen
6 months
Personality dimensions
Time Frame: 0 months
The Big Five Personality Test
0 months
Personality dimensions
Time Frame: 6 months
The Big Five Personality Test
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Helsinki
University of Eastern Finland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juha Tapanainen, professor, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TYH2020338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

According to request and after consideration of the study group

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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