Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment

Sponsor

Zealand University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04721938

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility Overweight and Obesity Weight Loss Vaginal Flora Imbalance DNA Damage	Behavioral: Systematic weight loss intervention	N/A

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:

Blood tests (metabolic markers), blood tests for Biobank and for miRNA biomarkers
Urine sample
Women: Endometrial biopsy and vaginal swab for microbiome testing
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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective cohort studyProspective cohort study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention Systematic weight loss intervention	Behavioral: Systematic weight loss 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 (Life-sum App) Motivational and adjustment dialogue and counselling with Nutritionist Nurse including anthropometric measures every month

Arm

Intervention/Treatment

Other: Intervention

Systematic weight loss intervention

Behavioral: Systematic weight loss 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 (Life-sum App) Motivational and adjustment dialogue and counselling with Nutritionist Nurse including anthropometric measures every month

Outcome Measures

Primary Outcome Measures

Weight loss [6 month]
The change in weight (in kilograms) from baseline to the 6 month

Secondary Outcome Measures

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 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 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)
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
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
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
Numbers of achieved pregnancy [Gestational week 4-8]
Both biochemical and clinical
Numbers of life births [From 9 month after inclusion]
Life birth

Other Outcome Measures

Blood pressure (Systolic and Diastolic) [6 months]
Metabolic and cardiovascular marker (blood sample) 2 [6 months]
The change in: Hemoglobin (mmol/L
Metabolic and cardiovascular marker (blood sample) 3 [6 months]
alanine Aminotransferase (ALT)(U/L)
Metabolic and cardiovascular marker (blood sample) 4 [6 months]
cholesterol (mmol/L)
Metabolic and cardiovascular marker (blood sample) 5 [6 months]
triglycerides (mmol/L)
Metabolic and cardiovascular marker (blood sample) 6 [6 months]
HbA1c (mmol/mol (IFCC)
Metabolic and cardiovascular marker (blood sample) 7 [6 months]
creatinine (µmol/L)
Metabolic and cardiovascular marker (blood sample) 8 [6 months]
fasting glucose level (mmol/L (eAG))