Somatic Stem Cells in Endometriosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Carlos Simon, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01412138
First received: July 28, 2011
Last updated: March 26, 2014
Last verified: March 2014
  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"

Resource links provided by NLM:


Further study details as provided by Igenomix:

Primary Outcome Measures:
  • 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: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ARM 1
ENDOMETRIAL SAMPLE
Other: genetic analysis
  1. 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.

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
Study Population

Women with endometrial infertility factor, undergoing ART.

Criteria

Inclusion Criteria:

Inclusion criteria for patients with endometriosis:

  1. Female patients with ovarian endometriosis, peritoneal and recto-vaginal.
  2. Aged between 20 and 40.
  3. Signing of informed consent for collection and storage of biological samples.

Exclusion Criteria:

  1. Contraindications for endometrial biopsy.
  2. Failure to sign informed consent for collection and storage of biological samples.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412138

Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Igenomix
Investigators
Principal Investigator: Carlos Simon, MDPhd IVI Valencia
  More Information

No publications provided

Responsible Party: Carlos Simon, Principal Investigator, Instituto Valenciano de Infertilidad, Spain
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 26, 2014
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 23, 2014