InfertilityNCT04721938
Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment
A study testing Systematic weight loss intervention in people with Infertility and Overweight and Obesity, run by Zealand University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infertility, Overweight and Obesity, Weight Loss
- What is being tested?
- Systematic weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2020to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI>30
- Referred to The Fertility Clinic, Zealand Region
Who cannot join
- Unable to speak and read Danish
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Systematic weight loss intervention
- Keywords
- female infertility, male infertility, life style intervention, vaginal microbiome, synthetic endocrine disrupting chemicals, EDCs, DNA fragmentation index, DFI, gene expression
- Medical subject headings
- Infertility, Overweight, Obesity, Weight Loss, Infertility, Female, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic weight loss interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Systematic weight loss intervention Receives: Behavioral: Systematic weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The change in weight (in kilograms) from baseline to the 6 month
Measured: 6 month
Secondary outcomes (11)
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),
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 months
Change in the DNA fragmentation index (DFI)
The change in DNA fragmentation index is measured by SPZlab using the SDI®-test
Measured: 6 months
Change in the vaginal microbiome
The change in the vaginal microbiome will be investigated at Statens Serum Institute (SSI), measured by PCR
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Numbers of achieved pregnancy
Both biochemical and clinical
Measured: Gestational week 4-8
Numbers of life births
Life birth
Measured: From 9 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 May 2020
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Lis Mikkelsen, MD, PhD, Study director, The Fertility Clinic, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721938
- Sponsor's protocol ID
- REG-048-2019
- Status last verified
- Jan 2023
- First submitted
- 16 Jun 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment
- ClinicalTrials.gov ID
- NCT04721938
- Acronym / sponsor ID
- REG-048-2019
- Keywords
- female infertility, male infertility, life style intervention, vaginal microbiome, synthetic endocrine disrupting chemicals, EDCs, DNA fragmentation index, DFI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Systematic weight loss interventionSystematic weight loss intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI>30
- Referred to The Fertility Clinic, Zealand Region
Key exclusion criteria (1 listed)
- Unable to speak and read Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic weight loss interventionWeight 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 | Behavioural | Intervention |
Primary outcome
Weight loss
Time frame: 6 month
The change in weight (in kilograms) from baseline to the 6 month
11 secondary outcomes
Change in the semen quality 1
Time frame: 6 months
Change in the semen quality 2
Time frame: 6 months
Change in the semen quality 3
Time frame: 6 months
Change in the semen quality 4
Time frame: 6 months
Change in the DNA fragmentation index (DFI)
Time frame: 6 months
Change in the vaginal microbiome
Time frame: 6 months
Change in the occurence of synthetic endocrine disruption chemicals (EDCs)
Time frame: 6 month
Change in MicroRNA
Time frame: 6 months
Change in the gene expression of gene involved in implantation
Time frame: 6 months
Numbers of achieved pregnancy
Time frame: Gestational week 4-8
Numbers of life births
Time frame: From 9 month after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Lis Mikkelsen, MD, PhD study director
The Fertility Clinic, Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic weight loss intervention in people with Infertility and Overweight and Obesity, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.