COaching Lifestyle Intervention for FErtility (COLIFE)

H

Helsinki University Central Hospital (HUCH)

Status

Not yet enrolling

Conditions

Fertility Disorders
Life Style

Treatments

Behavioral: Life Style

Study type

Interventional

Funder types

Other

Identifiers

NCT04589793
TYH2020338

Details and patient eligibility

About

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.

Enrollment

1,560 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,560 participants in 2 patient groups

Control
No Intervention group
Description:
Conventional treatment
Intervention
Active Comparator group
Description:
Motivational interview
Treatment:
Behavioral: Life Style

Trial contacts and locations

0

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Central trial contact

Paivi Joki-Korpela, PhD; Maritta Poyhonen-Alho, PhD

Data sourced from clinicaltrials.gov

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