Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment

Infertility Clinical Trial

Official title:

Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721938
• Other study ID #: REG-048-2019
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: April 27, 2022

Study information

• Verified date: January 2023
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BMI>30

• Referred to The Fertility Clinic, Zealand Region

Exclusion Criteria:

• Unable to speak and read Danish

Related Conditions & MeSH terms

• Body Weight
• DNA Damage
• Infertility
• Overweight
• Overweight and Obesity
• Vaginal Flora Imbalance
• 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

Locations

Country	Name	City	State
Denmark	The Fertility Clinic, Zealand University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure (Systolic and Diastolic)		6 months
Other	Metabolic and cardiovascular marker (blood sample) 2	The change in: Hemoglobin (mmol/L	6 months
Other	Metabolic and cardiovascular marker (blood sample) 3	alanine Aminotransferase (ALT)(U/L)	6 months
Other	Metabolic and cardiovascular marker (blood sample) 4	cholesterol (mmol/L)	6 months
Other	Metabolic and cardiovascular marker (blood sample) 5	triglycerides (mmol/L)	6 months
Other	Metabolic and cardiovascular marker (blood sample) 6	HbA1c (mmol/mol (IFCC)	6 months
Other	Metabolic and cardiovascular marker (blood sample) 7	creatinine (µmol/L)	6 months
Other	Metabolic and cardiovascular marker (blood sample) 8	fasting glucose level (mmol/L (eAG))	6 months
Primary	Weight loss	The change in weight (in kilograms) from baseline to the 6 month	6 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in the DNA fragmentation index (DFI)	The change in DNA fragmentation index is measured by SPZlab using the SDI®-test	6 months
Secondary	Change in the vaginal microbiome	The change in the vaginal microbiome will be investigated at Statens Serum Institute (SSI), measured by PCR	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Numbers of achieved pregnancy	Both biochemical and clinical	Gestational week 4-8
Secondary	Numbers of life births	Life birth	From 9 month after inclusion