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COaching Lifestyle Intervention for FErtility

NCT04589793 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1560

Last updated 2021-08-12

No results posted yet for this study

Summary

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.

Conditions

  • Life Style
  • Fertility Disorders

Interventions

BEHAVIORAL

Life Style

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

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • University of Eastern Finland

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Juha Tapanainen, professor · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2024-09-30
Completion
2025-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589793 on ClinicalTrials.gov