NCT01468935

Brief Summary

Background: \- Some transplant recipients have been found to have cells in their uterus that come from the donor. Researchers want to study uterine tissue from three different groups of women: (1) healthy volunteers, (2) people who have had a stem cell transplant, and (3) people with rare diseases or conditions that affect reproduction. These samples will help researchers learn more about the way stem cells work in the reproductive tract. Objectives: \- To collect cells from the uterus to study how stem cells work in the reproductive tract. Eligibility: \- Women at least 18 years of age. Design:

  • Participants will be screened with a physical exam and medical history. They will also have blood and urine tests.
  • Participants will have an endometrial biopsy to collect cells for study. The biopsy visit will take 1 to 2 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2017

Completed
Last Updated

December 17, 2019

Status Verified

September 21, 2017

First QC Date

November 8, 2011

Last Update Submit

December 14, 2019

Conditions

EndometriosisStem Cell TransplantHealthy Volunteers

Keywords

UterusEndometriumBone Marrow TransplantGynecologyHealthy VolunteerHVStem Cell TransplantEndometriosis

Outcome Measures

Primary Outcomes (1)

  • To study if endometiral stem cells are different in normal and disease states.

Secondary Outcomes (1)

  • To study if the type of hematopoietic transplantation regimen affects uterine engraftment of donor stem cells.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is able to give consent/assent to participate in the protocol.
  • Age greater than or equal to 18 years old
  • Female gender
  • Presence of a uterus
  • Fall into one of the following categories:
  • Healthy volunteers
  • Hematologic patients:
  • Whole bone marrow transplant recipients
  • Peripheral blood stem cell transplant recipients
  • Mesenchymal stem cell transplant recipients
  • Bone marrow or stem cell donors
  • Fully ablative transplant recipients
  • Nonmyeloablative transplant recipients
  • Cord blood transplant recipients
  • Rare, interesting, or unique reproductive phenotypes that may provide insight to endometrial function in health and disease:
  • +7 more criteria

You may not qualify if:

  • Unable to comprehend the investigational nature of the protocol participation.
  • Positive pregnancy test.
  • Anticoagulation or known coagulopathy.
  • Active gonorrhea or Chlamydia infections or pelvic inflammatory disease within the last 3 months.
  • Previous hysterectomy or endometrial ablation procedure.
  • Thrombocytopenia (\<50,000).
  • Uterine or cervical cancer.
  • Cervical stenosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Bhanu NV, Trice TA, Lee YT, Gantt NM, Oneal P, Schwartz JD, Noel P, Miller JL. A sustained and pancellular reversal of gamma-globin gene silencing in adult human erythroid precursor cells. Blood. 2005 Jan 1;105(1):387-93. doi: 10.1182/blood-2004-04-1599. Epub 2004 Sep 14.

    PMID: 15367428BACKGROUND

  • Ogawa M, LaRue AC, Drake CJ. Hematopoietic origin of fibroblasts/myofibroblasts: Its pathophysiologic implications. Blood. 2006 Nov 1;108(9):2893-6. doi: 10.1182/blood-2006-04-016600. Epub 2006 Jul 13.

    PMID: 16840726BACKGROUND

  • Taylor HS. Endometrial cells derived from donor stem cells in bone marrow transplant recipients. JAMA. 2004 Jul 7;292(1):81-5. doi: 10.1001/jama.292.1.81.

    PMID: 15238594BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Alan H DeCherney, M.D.

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 10, 2011

Study Start

October 31, 2011

Study Completion

September 21, 2017

Last Updated

December 17, 2019

Record last verified: 2017-09-21

Locations

US(1)