NCT04721938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

June 16, 2020

Last Update Submit

January 23, 2023

Conditions

InfertilityOverweight and ObesityWeight LossVaginal Flora ImbalanceDNA Damage

Keywords

female infertilitymale infertilitylife style interventionvaginal microbiomesynthetic endocrine disrupting chemicalsEDCsDNA fragmentation indexDFIgene expression

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    The change in weight (in kilograms) from baseline to the 6 month

    6 month

Secondary Outcomes (11)

  • Change in the semen quality 1

    6 months

  • Change in the semen quality 2

    6 months

  • Change in the semen quality 3

    6 months

  • Change in the semen quality 4

    6 months

  • Change in the DNA fragmentation index (DFI)

    6 months

  • +6 more secondary outcomes

Other Outcomes (8)

  • Blood pressure (Systolic and Diastolic)

    6 months

  • Metabolic and cardiovascular marker (blood sample) 2

    6 months

  • Metabolic and cardiovascular marker (blood sample) 3

    6 months

  • +5 more other outcomes

Study Arms (1)

Intervention

OTHER

Systematic weight loss intervention

Behavioral: Systematic weight loss intervention

Interventions

Systematic weight loss interventionBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to speak and read Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fertility Clinic, Zealand University Hospital

Køge, Denmark

Location

MeSH Terms

Conditions

InfertilityOverweightObesityWeight LossInfertility, FemaleInfertility, Male

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, MaleMale Urogenital Diseases

Study Officials

  • Anne Lis Mikkelsen, MD, PhD

    The Fertility Clinic, Zealand University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

January 25, 2021

Study Start

May 1, 2020

Primary Completion

April 27, 2022

Study Completion

April 27, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

DK(1)