Clinical trial NCT04721938: Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment
Official title: Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Overweight and Obesity
Weight Loss
Vaginal Flora Imbalance
DNA Damage
Keywords: female infertility
male infertility
life style intervention
vaginal microbiome
synthetic endocrine disrupting chemicals
EDCs
DNA fragmentation index
DFI
gene expression
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* BMI\>30
* Referred to The Fertility Clinic, Zealand Region

Exclusion Criteria:

* Unable to speak and read Danish

Primary outcomes:
measure: Weight loss
timeFrame: 6 month
Secondary outcomes:
measure: Change in the semen quality 1
timeFrame: 6 months
measure: Change in the semen quality 2
timeFrame: 6 months
measure: Change in the semen quality 3
timeFrame: 6 months
measure: Change in the semen quality 4
timeFrame: 6 months
measure: Change in the DNA fragmentation index (DFI)
timeFrame: 6 months
measure: Change in the vaginal microbiome
timeFrame: 6 months
measure: Change in the occurence of synthetic endocrine disruption chemicals (EDCs)
timeFrame: 6 month
measure: Change in MicroRNA
timeFrame: 6 months
measure: Change in the gene expression of gene involved in implantation
timeFrame: 6 months
measure: Numbers of achieved pregnancy
timeFrame: Gestational week 4-8
measure: Numbers of life births
timeFrame: From 9 month after inclusion
Other outcomes:
measure: Blood pressure (Systolic and Diastolic)
timeFrame: 6 months
measure: Metabolic and cardiovascular marker (blood sample) 2
timeFrame: 6 months
measure: Metabolic and cardiovascular marker (blood sample) 3
timeFrame: 6 months
measure: Metabolic and cardiovascular marker (blood sample) 4
timeFrame: 6 months
measure: Metabolic and cardiovascular marker (blood sample) 5
timeFrame: 6 months
measure: Metabolic and cardiovascular marker (blood sample) 6
timeFrame: 6 months
measure: Metabolic and cardiovascular marker (blood sample) 7
timeFrame: 6 months
measure: Metabolic and cardiovascular marker (blood sample) 8
timeFrame: 6 months
Locations:
city: Køge
country: Denmark
facility: The Fertility Clinic, Zealand University Hospital
Study officials:
affiliation: The Fertility Clinic, Zealand University Hospital
name: Anne Lis Mikkelsen, MD, PhD
role: STUDY_DIRECTOR
References: