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Endometriosis, Food Consumption and Fertility

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ClinicalTrials.gov Identifier: NCT01946698
Recruitment Status : Recruiting
First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Ulla Breth Knudsen, University of Aarhus

Brief Summary:
To investigate parameters related to fertility in women with endometriosis in relation to food items.

Condition or disease
Endometriosis

Detailed Description:
The study has been reviewed and accepted by the legal registrations in Denmark (The Regional Committee on Biomedical Research Ethics and The Danish Dataprotection Agency). The data will be anonymous and kept as described by the Danish register law.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: A Study on the Differences in Inflammatory Markers Between Women With Endometriosis and Women Without in Relation to Fertility and Food Consumption.
Study Start Date : June 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : September 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort
Fertility patients
Women with endometriosis compared to women without endometriosis. Different samples will be collected (blood, follicular fluid, cells from the uterus)



Primary Outcome Measures :
  1. The level of Free Fatty Acid in follicular fluid will be different in women with endometriosis compared to controls [ Time Frame: The fluid will be collected, frozen and tested december 2014 ]

Secondary Outcome Measures :
  1. methylation pattern of specific genes in the endometrium [ Time Frame: Collecting of cells and testing december 2014 ]
    The cells will be collected from infertile women with or without endometriosis, frozen and tested later.


Biospecimen Retention:   Samples With DNA
Blood samples for inflammatory markers, hormones and genetic testing. Follicular fluid for inflammatory markers. Cells from the uterus for testing of different additives and what characterize cells from women with endometriosis compared to controls.


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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women attending an infertility Clinic, some with endometriosis compared to women without endometriosis
Criteria

Inclusion Criteria:

  • Fertility patients

Exclusion Criteria:

  • mental challenges

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946698


Contacts
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Contact: Ulla B Knudsen, Professor +4578453348 ullaknud@rm.dk
Contact: Pia M Martensen, Ph.D. +4528992032

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Ulla B Knudsen, Professor    +4578453348    ullaknud@rm.dk   
Sub-Investigator: Ulla B Knudsen, Professor         
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Ulla B Knudsen, Professor Professor, Consultant at the Fertility Clinic, Arhus University Hospital
Additional Information:

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Responsible Party: Ulla Breth Knudsen, Professor, Consultant, Ph.D., University of Aarhus
ClinicalTrials.gov Identifier: NCT01946698    
Other Study ID Numbers: Endo
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Endometriosis