EndometriosisNCT01412138
Somatic Stem Cells in Endometriosis
An observational study of Endometriosis, run by Igenomix at 1 site in Spain.
Trial summary
Human endometrium is a very dynamic tissue characterized by cyclical process of proliferation, differentiation and cellular shedding as part of each menstrual cycle. This issue suggests the presence of somatic stem cells. Endometriosis is characterized by presence of endometrium outside the uterine cavity. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- genetic analysis
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with endometrial infertility factor, undergoing ART.
Who may be able to join
- Female patients with ovarian endometriosis, peritoneal and recto-vaginal.
- Aged between 20 and 40.
- Signing of informed consent for collection and storage of biological samples.
Who cannot join
- Contraindications for endometrial biopsy.
- Failure to sign informed consent for collection and storage of biological samples.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Identification, Characterization and Isolation of Somatic Stem Cells in Human Endometrium of Women With Endometriosis"
Human endometrium is a very dynamic tissue characterized by cyclical process of proliferation, differentiation and cellular shedding as part of each menstrual cycle. This issue suggests the presence of somatic stem cells. Endometriosis is characterized by presence of endometrium outside the uterine cavity. The existence of a somatic stem cell population in endometrium could explain the incorrect proliferation of these cells, which would lead to formation of endometriotic foci.
Read the detailed description
Throughout the life of the woman, the endometrium undergoes a series of continuous modifications that require a highly accurate feedback mechanism and specialized and must be based on the activity of the stem cell population.
Endometriosis is an estrogen-dependent chronic disease characterized by the presence of functional endometrium outside the uterine cavity, mainly in the peritoneum and ovary (Giudice and Kao, 2004). It affects 6-10% of women of reproductive age, often resulting in a series of gynecological problems, including dysmenorrhea, pelvic pain and infertility. The nature of endometriosis suggests that the initiation of ectopic endometrial lesions may be due to stem or progenitor cells, which is consistent with the theory of retrograde menstruation (Starzinski-Powitz et al. 2001; Leyendecker et al. 2002, Gargett, 2006; Gargett, 2007, Sasson and Taylor, 2008). To date, no direct evidence of the role of somatic stem cells of the endometrium in the pathogenesis of endometriosis. However, numerous studies show that ectopic endometrial cells implant in many established models used for the study of endometriosis.(Masuda et al., 2007b; Sasson and Taylor, 2008; Gargett y Masuda.,2010)
- Conditions
- Endometriosis
- Being tested
- genetic analysis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic analysisOther
- To identify by flow cytometry through technique of "Side Population" the population of somatic stem cells present in both human endometrial eutopic and ectopic endometrium of women with ovarian endometriosis, peritoneal and recto-vaginal.
- In vitro culture conditions for cell proliferation.
- To characterize the somatic stem cell population using techniques of endometriotic cell and molecular biology.
- Compare the results obtained from patients with endometriosis with control patients (without endometriosis) earlier work by our group.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | ENDOMETRIAL SAMPLE Receives: Other: genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of endometrial stem cells through Flow Citometry and Side Population techniques and In vitro culture cellular proliferation to then characterize the cell population through molecular and cellular techniques.
Measured: TWO YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Carlos Simon, MDPhd, Principal investigator, IVI Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412138
- Sponsor's protocol ID
- 1006-C-073-CS-F
- Status last verified
- Apr 2015
- First submitted
- 28 Jul 2011
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Identification, Characterization and Isolation of Somatic Stem Cells in Human Endometrium of Women With Endometriosis"
- ClinicalTrials.gov ID
- NCT01412138
- Acronym / sponsor ID
- 1006-C-073-CS-F
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 9 Aug 2011 (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.
Human endometrium is a very dynamic tissue characterized by cyclical process of proliferation, differentiation and cellular shedding as part of each menstrual cycle. This issue suggests the presence of somatic stem cells. Endometriosis is characterized by presence of endometrium outside the uterine cavity. The existence of a somatic stem cell population in endometrium could explain the incorrect proliferation of these cells, which would lead to formation of endometriotic foci.
Detailed description
Throughout the life of the woman, the endometrium undergoes a series of continuous modifications that require a highly accurate feedback mechanism and specialized and must be based on the activity of the stem cell population.
Endometriosis is an estrogen-dependent chronic disease characterized by the presence of functional endometrium outside the uterine cavity, mainly in the peritoneum and ovary (Giudice and Kao, 2004). It affects 6-10% of women of reproductive age, often resulting in a series of gynecological problems, including dysmenorrhea, pelvic pain and infertility. The nature of endometriosis suggests that the initiation of ectopic endometrial lesions may be due to stem or progenitor cells, which is consistent with the theory of retrograde menstruation (Starzinski-Powitz et al. 2001; Leyendecker et al. 2002, Gargett, 2006; Gargett, 2007, Sasson and Taylor, 2008). To date, no direct evidence of the role of somatic stem cells of the endometrium in the pathogenesis of endometriosis. However, numerous studies show that ectopic endometrial cells implant in many established models used for the study of endometriosis.(Masuda et al., 2007b; Sasson and Taylor, 2008; Gargett y Masuda.,2010)
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | – | Other: genetic analysisENDOMETRIAL SAMPLE |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with endometrial infertility factor, undergoing ART.
Key inclusion criteria (3 listed)
- Female patients with ovarian endometriosis, peritoneal and recto-vaginal.
- Aged between 20 and 40.
- Signing of informed consent for collection and storage of biological samples.
Key exclusion criteria (2 listed)
- Contraindications for endometrial biopsy.
- Failure to sign informed consent for collection and storage of biological samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic analysis1. To identify by flow cytometry through technique of "Side Population" the population of somatic stem cells present in both human endometrial eutopic and ectopic endometrium of women with ovarian endometriosis, peritoneal and recto-vaginal. 2. In vitro culture conditions for cell proliferation. 3. To characterize the somatic stem cell population using techniques of endometriotic cell and molecular biology. 4. Compare the results obtained from patients with endometriosis with control patients (without endometriosis) earlier work by our group. | Other | ARM 1 |
Primary outcome
Characterization of endometrial stem cells through Flow Citometry and Side Population techniques and In vitro culture cellular proliferation to then characterize the cell population through molecular and cellular techniques.
Time frame: TWO YEARS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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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. This study is not recruiting at the moment.
Carlos Simon, MDPhd principal investigator
IVI Valencia
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 Igenomix at 1 site in Spain.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Apr 2015. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of endometrial stem cells through Flow Citometry and Side Population techniques and In vitro culture cellular proliferation to then characterize the cell population through molecular and cellular techniques. (time frame: TWO YEARS). 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 22 Apr 2015.