Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment
- Conditions
- InfertilityOverweight and ObesityVaginal Flora ImbalanceWeight LossDNA Damage
- Interventions
- Behavioral: Systematic weight loss intervention
- Registration Number
- NCT04721938
- Lead Sponsor
- Zealand University Hospital
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- BMI>30
- Referred to The Fertility Clinic, Zealand Region
- Unable to speak and read Danish
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Systematic weight loss intervention Systematic weight loss intervention
- Primary Outcome Measures
Name Time Method Weight loss 6 month The change in weight (in kilograms) from baseline to the 6 month
- Secondary Outcome Measures
Name Time Method Change in the semen quality 1 6 months 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),
Change in the semen quality 3 6 months 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)
Numbers of life births From 9 month after inclusion Life birth
Change in the semen quality 2 6 months 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)
Change in the semen quality 4 6 months 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)
Change in the DNA fragmentation index (DFI) 6 months The change in DNA fragmentation index is measured by SPZlab using the SDI®-test
Numbers of achieved pregnancy Gestational week 4-8 Both biochemical and clinical
Change in the gene expression of gene involved in implantation 6 months The change in the gene expression in the endometrium is analysed by Department of Science and Environment, RUC
Change in the vaginal microbiome 6 months The change in the vaginal microbiome will be investigated at Statens Serum Institute (SSI), measured by PCR
Change in the occurence of synthetic endocrine disruption chemicals (EDCs) 6 month 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
Change in MicroRNA 6 months The change in MicroRNA will be measured froom blood samples and is is analysed by Department of Science and Environment, RUC
Trial Locations
- Locations (1)
The Fertility Clinic, Zealand University Hospital
🇩🇰Køge, Denmark