Somatic Stem Cells in Endometriosis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Endometriosis |
Other: genetic analysis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | "Identification, Characterization and Isolation of Somatic Stem Cells in Human Endometrium of Women With Endometriosis" |
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
endometrial biopsy
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
ARM 1
ENDOMETRIAL SAMPLE
|
Other: genetic analysis
|
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)
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Women with endometrial infertility factor, undergoing ART.
Inclusion Criteria:
Inclusion criteria for patients with endometriosis:
- 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.
Exclusion Criteria:
- Contraindications for endometrial biopsy.
- Failure to sign informed consent for collection and storage of biological samples.
Contacts and Locations| Contact: Claudia Gil, PhD | +34 963289681 | claudia.gil@ivi.es |
| Contact: Leslie Atkinson, MA | +34 963050900 | leslie.atkinson@ivi.es |
| Spain | |
| IVI Valencia | Recruiting |
| Valencia, Spain, 46015 | |
| Contact: Leslie Atkinson, MA +34 963050900 leslie.atkinson@ivi.es | |
| Contact: Claudia Gil, PhD +34 963289681 claudia.gil@ivi.es | |
| Principal Investigator: Carlos Simón, MD PhD | |
| Sub-Investigator: Claudia Gil, PhD | |
| Principal Investigator: | Carlos Simon, MDPhd | IVI Valencia |
More Information
No publications provided
| Responsible Party: | Dr. Carlos Simón, IVI Valencia |
| ClinicalTrials.gov Identifier: | NCT01412138 History of Changes |
| Other Study ID Numbers: | 1006-C-073-CS-F |
| Study First Received: | July 28, 2011 |
| Last Updated: | March 30, 2012 |
| Health Authority: | Spain: Ministry of Health |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 22, 2013