Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04721938
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2020-06-16
Brief Title:
Healthy Parents - Healthy Children Weight Loss Before Fertility Treatment
Sponsor:
Zealand University Hospital
Organization:
Zealand University Hospital
Study Overview
Official Title:
Healthy Parents - Healthy Children Weight Loss Before Fertility Treatment
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The detrimental effect of overweight and obesity on fecundity has been well documented
The investigators wish to investigate the intervention program for weight loss before fertility treatment
Subsequently to gain knowledge on the effect of overweightobesity and weight loss on the vaginal microbiome on DNA damage on sperm cells on the occurrence of endocrine disruptors in the endometrium and on the gene expression in the endometrium
The investigators wish to investigate the intervention program for weight loss before fertility treatment
Subsequently to gain knowledge on the effect of overweightobesity and weight loss on the vaginal microbiome on DNA damage on sperm cells on the occurrence of endocrine disruptors in the endometrium and on the gene expression in the endometrium
Detailed Description:
Purpose and aim of the study The Fertility Clinic at Zealand University Hospital wishes to introduce a new care concept Healthy Parents - Healthy Children with the purpose of changing the behaviours of infertile men and women towards a healthier life style now and for future generations
The Zealand Region includes areas of significant deprivation compared to Copenhagen and has a higher prevalence of obesity and poor diet
These inequalities generate socio-demographic and long-term health challenges decrease the chance of becoming pregnant and increase risk of life style related diseases for parents and their offspring in the long term
The waiting time before fertility treatment 12 months in the region represents a unique window of opportunity to encourage long-term life style changes The aforementioned reasons initiated the planned Preconception Clinic Healthy Parents - Healthy Children
The Preconception Clinic utilises waiting list time to optimise parental health prior to conception We will provide weight loss interventions aimed at helping the patients to a healthier lifestyle an increased chance of conception and a decreased risk of life style diseases for themselves and their future offspring
Purpose of study
Patient weight loss of at least 10 at the end of intervention and at annular follow up until 5 years
Study population Sub-fertile population referred to the Fertility Clinic Region Zealand due to infertility
Inclusion criteria
20 women and 20 men with a BMI30 age 18-40 years
Exclusion criteria
Inability to understand the written and oral information
Baseline and end of intervention-sampling
1 Blood tests metabolic markers blood tests for Biobank and for miRNA biomarkers
2 Urine sample
3 Women Endometrial biopsy and vaginal swab for microbiome testing
4 Men Sperm sample
Intervention Weight reduction through life style changes in diet and exercise by the following means
Counselling with a Nutritionist Nurse on diet and exercise
Online smartphone coaching program LifeSum-App
Motivational and adjustment dialogue and counselling with Nutritionist Nurse including anthropometric measures every month
Primary endpoint Weight loss of at least 10
Anticipated impact The aim of this study is to find a feasible intervention that can change adverse life styles in a preconception setting Elements from the weight loss intervention can be incorporated to the broader community for instance as Preconception weight loss packages in the local municipalities aimed at optimizing health before conception in the general fertile population
The Zealand Region includes areas of significant deprivation compared to Copenhagen and has a higher prevalence of obesity and poor diet
These inequalities generate socio-demographic and long-term health challenges decrease the chance of becoming pregnant and increase risk of life style related diseases for parents and their offspring in the long term
The waiting time before fertility treatment 12 months in the region represents a unique window of opportunity to encourage long-term life style changes The aforementioned reasons initiated the planned Preconception Clinic Healthy Parents - Healthy Children
The Preconception Clinic utilises waiting list time to optimise parental health prior to conception We will provide weight loss interventions aimed at helping the patients to a healthier lifestyle an increased chance of conception and a decreased risk of life style diseases for themselves and their future offspring
Purpose of study
Patient weight loss of at least 10 at the end of intervention and at annular follow up until 5 years
Study population Sub-fertile population referred to the Fertility Clinic Region Zealand due to infertility
Inclusion criteria
20 women and 20 men with a BMI30 age 18-40 years
Exclusion criteria
Inability to understand the written and oral information
Baseline and end of intervention-sampling
1 Blood tests metabolic markers blood tests for Biobank and for miRNA biomarkers
2 Urine sample
3 Women Endometrial biopsy and vaginal swab for microbiome testing
4 Men Sperm sample
Intervention Weight reduction through life style changes in diet and exercise by the following means
Counselling with a Nutritionist Nurse on diet and exercise
Online smartphone coaching program LifeSum-App
Motivational and adjustment dialogue and counselling with Nutritionist Nurse including anthropometric measures every month
Primary endpoint Weight loss of at least 10
Anticipated impact The aim of this study is to find a feasible intervention that can change adverse life styles in a preconception setting Elements from the weight loss intervention can be incorporated to the broader community for instance as Preconception weight loss packages in the local municipalities aimed at optimizing health before conception in the general fertile population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None