Infertility Clinical Trial
Official title:
Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment
NCT number | NCT04721938 |
Other study ID # | REG-048-2019 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2020 |
Est. completion date | April 27, 2022 |
Verified date | January 2023 |
Source | Zealand University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | The Fertility Clinic, Zealand University Hospital | Køge |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital |
Denmark,
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 |
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