COaching Lifestyle Intervention for FErtility

NCT ID: NCT04589793

Last Updated: 2021-08-12

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

1560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Life Style Fertility Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Motivational interview

Group Type ACTIVE_COMPARATOR

Life Style

Intervention Type BEHAVIORAL

Life Style intervention including physical activity, diet, sleep and stress

Interventions

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Life Style

Life Style intervention including physical activity, diet, sleep and stress

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maritta Poyhonen-Alho

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juha Tapanainen, professor

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Central Contacts

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Maritta Poyhonen-Alho, PhD

Role: CONTACT

+358 50 428 4690

Paivi Joki-Korpela, PhD

Role: CONTACT

Other Identifiers

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TYH2020338

Identifier Type: -

Identifier Source: org_study_id

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