Status:
COMPLETED
Bone Marrow Cell Engraftment of the Uterus and Genetic Studies of Reproductive Functioning
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Endometriosis
Stem Cell Transplant
Eligibility:
FEMALE
18+ years
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) he...
Detailed Description
Transplantation with hematopoietic cells has been used for a wide variety of blood disorders, but also for diseases like solid organ cancers. Interestingly, women who have had bone marrow transplants ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subject is able to give consent/assent to participate in the protocol.
- Listed below are acceptable medical conditions for inclusion in this 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:
- Asherman s syndrome
- Endometriosis
- Abnormal uterine bleeding
- Recurrent pregnancy loss
- Infertility
- Implantation failure
- Reproductive disorders
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
October 31 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 21 2017
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01468935
Start Date
October 31 2011
End Date
September 21 2017
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892