NCT01946698

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
52mo left

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress75%
Jun 2013Sep 2030

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
13.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Expected
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

3.5 years

First QC Date

August 18, 2013

Last Update Submit

September 19, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • The level of Free Fatty Acid in follicular fluid will be different in women with endometriosis compared to controls

    The fluid will be collected, frozen and tested december 2014

Secondary Outcomes (1)

  • methylation pattern of specific genes in the endometrium

    Collecting of cells and testing december 2014

Study Arms (1)

Fertility patients

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

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women attending an infertility Clinic, some with endometriosis compared to women without endometriosis

You may qualify if:

  • Fertility patients

You may not qualify if:

  • mental challenges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

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.

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ulla B Knudsen, Professor

    Professor, Consultant at the Fertility Clinic, Arhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulla B Knudsen, Professor

CONTACT

Pia M Martensen, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Consultant, Ph.D.

Study Record Dates

First Submitted

August 18, 2013

First Posted

September 20, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2016

Study Completion (Estimated)

September 1, 2030

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations