Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Weight Loss; Overweight and Obesity; DNA Damage; Vaginal Flora Imbalance
• Intervention / Treatment: Behavioral: Systematic weight loss intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Køge, Denmark
    • The Fertility Clinic, Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI>30
• Referred to The Fertility Clinic, Zealand Region

Exclusion Criteria:

• Unable to speak and read Danish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	The change in weight (in kilograms) from baseline to the 6 month	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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),	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)	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)	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)	6 months
Change in the DNA fragmentation index (DFI)	The change in DNA fragmentation index is measured by SPZlab using the SDI®-test	6 months
Change in the vaginal microbiome	The change in the vaginal microbiome will be investigated at Statens Serum Institute (SSI), measured by PCR	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	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	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	6 months
Numbers of achieved pregnancy	Both biochemical and clinical	Gestational week 4-8
Numbers of life births	Life birth	From 9 month after inclusion

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Study Director: Anne Lis Mikkelsen, MD, PhD, The Fertility Clinic, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: gene expression; male infertility; DFI; vaginal microbiome; life style intervention; female infertility; synthetic endocrine disrupting chemicals; EDCs; DNA fragmentation index
• Additional Relevant MeSH Terms: Body Weight Changes; Infertility; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: REG-048-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No