EndometriosisNCT01946698
Endometriosis, Food Consumption and Fertility
An observational study of Endometriosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
To investigate parameters related to fertility in women with endometriosis in relation to food items. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2013to Sep 2030
- How long will I take part?
- 4 Months
- Phase
- Observational
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 to 41 years
- Women only
- No healthy volunteers
- Adult
Study population: Women attending an infertility Clinic, some with endometriosis compared to women without endometriosis
Who may be able to join
- Fertility patients
Who cannot join
- mental challenges
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pia M Martensen, Ph.D. contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Ulla B Knudsen, Professor, +4578453348, ullaknud@rm.dk
Ulla B Knudsen, Professor
About this study
Official title: A Study on the Differences in Inflammatory Markers Between Women With Endometriosis and Women Without in Relation to Fertility and Food Consumption.
To investigate parameters related to fertility in women with endometriosis in relation to food items.
Read the 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.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fertility patients | Women with endometriosis compared to women without endometriosis. Different samples will be collected (blood, follicular fluid, cells from the uterus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of Free Fatty Acid in follicular fluid will be different in women with endometriosis compared to controls
Measured: The fluid will be collected, frozen and tested december 2014
Secondary outcomes (1)
methylation pattern of specific genes in the endometrium
The cells will be collected from infertile women with or without endometriosis, frozen and tested later.
Measured: Collecting of cells and testing december 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Breth Knudsen, University of Aarhus
- Investigators
- Ulla B Knudsen, Professor, Principal investigator, Professor, Consultant at the Fertility Clinic, Arhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946698
- Sponsor's protocol ID
- Endo
- Status last verified
- Sep 2013
- First submitted
- 18 Aug 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No