COaching Lifestyle Intervention for FErtility (COLIFE)

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)

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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