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 overweight/obesity 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.
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 BMI\>30, 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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 (Life-sum App) * Motivational and adjustment dialogue and counselling with Nutritionist Nurse including anthropometric measures every month
The Fertility Clinic, Zealand University Hospital
Køge, Denmark
Weight loss
The change in weight (in kilograms) from baseline to the 6 month
Time frame: 6 month
Change in the semen quality 1
The change in the morphological semen parameters, from baseline to 6 month will be measured by using WHO recommendation for semen analysis: Sperm count (mill/ml),
Time frame: 6 months
Change in the semen quality 2
The change in the morphological semen parameters, from baseline to 6 month will be measured by using WHO recommendation for semen analysis: Sperm concentration (ml)
Time frame: 6 months
Change in the semen quality 3
The change in the morphological semen parameters, from baseline to 6 month will be measured by using WHO recommendation for semen analysis: Sperm motility (mill/ml)
Time frame: 6 months
Change in the semen quality 4
The change in the morphological semen parameters, from baseline to 6 month will be measured by using WHO recommendation for semen analysis: Sperm morphology (percent)
Time frame: 6 months
Change in the DNA fragmentation index (DFI)
The change in DNA fragmentation index is measured by SPZlab using the SDI®-test
Time frame: 6 months
Change in the vaginal microbiome
The change in the vaginal microbiome will be investigated at Statens Serum Institute (SSI), measured by PCR
Time frame: 6 months
Change in the occurence of synthetic endocrine disruption chemicals (EDCs)
The change in the occurrence of synthetic endocrine disruption chemicals (EDCs) endometrium is measured by The Department of Growth and Reproduction at Rigshospitalet by using LC-MS/MS analyze
Time frame: 6 month
Change in MicroRNA
The change in MicroRNA will be measured froom blood samples and is is analysed by Department of Science and Environment, RUC
Time frame: 6 months
Change in the gene expression of gene involved in implantation
The change in the gene expression in the endometrium is analysed by Department of Science and Environment, RUC
Time frame: 6 months
Numbers of achieved pregnancy
Both biochemical and clinical
Time frame: Gestational week 4-8
Numbers of life births
Life birth
Time frame: From 9 month after inclusion
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