Somatic Stem Cells in Endometriosis

NCT01412138 | Unknown

• 1 other identifier: 1006-C-073-CS-F
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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.

  TWO YEARS

Study Arms (1)

ARM 1

ENDOMETRIAL SAMPLE

Other: genetic analysis

Interventions

genetic analysis OTHER

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.

ARM 1

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with endometrial infertility factor, undergoing ART.

You may qualify if:

• 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.

You may not qualify if:

• Contraindications for endometrial biopsy.
• Failure to sign informed consent for collection and storage of biological samples.

Sponsors & Collaborators

• Igenomix: lead

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

endometrial biopsy

MeSH Terms

Conditions

Endometriosis

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Carlos Simon, MDPhd

  IVI Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 9, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

ES (1)