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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Differences in Inflammatory Markers Between Women With Endometriosis and Women Without in Relation to Fertility and Food Consumption.
- ClinicalTrials.gov ID
- NCT01946698
- Acronym / sponsor ID
- Endo
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate parameters related to fertility in women with endometriosis in relation to food items.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fertility patients | – | –Women with endometriosis compared to women without endometriosis. Different samples will be collected (blood, follicular fluid, cells from the uterus) |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women attending an infertility Clinic, some with endometriosis compared to women without endometriosis
Key inclusion criteria (1 listed)
- Fertility patients
Key exclusion criteria (1 listed)
- mental challenges
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
methylation pattern of specific genes in the endometrium
Time frame: Collecting of cells and testing december 2014
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pia M Martensen, Ph.D. contact
Ulla B Knudsen, Professor principal investigator
Professor, Consultant at the Fertility Clinic, Arhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulla B Knudsen, Professor (+4578453348, ullaknud@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.