Immunologic evaluation of the endometrium with a LNG-IUS in immunocompromised women and healthy controls
Awarded 2013
Complex Family Planning Fellowship Research
Caron Kim, MD, MS
University of California, Los Angeles

Currently, there is a general unease of providers to recommend the intrauterine device (IUD) as a plausible birth control method for their solid organ transplant patients.  It is not uncommon to receive a consult from the transplant team to either remove a patient’s IUD or to prevent its placement for fear that there will be an increase in infection or decrease in efficacy.  This is happening even when the patient herself desires its placement or is already satisfied with the IUD as her birth control method.  Part of this unease stems from the scarcity of evidence that the IUD is safe and effective in this population.  Evidence from the HIV population group reveals the IUD’s safety and efficacy.
However, it is unknown what exactly occurs in the uterus of the stable solid organ transplant patient.   If immune/inflammatory mechanisms in the endometrium of immunocompromised patient were seen to be similar to that seen in healthy women, we can start on the pathway of reassurance that the IUD is a feasible birth control method option for the transplant patient.
The project is a pilot study that investigates the endometrial environment of the stable, solid organ transplant patient and healthy women.   The overall objective of the study is to determine if any difference exists between the transplant patient’s endometrium and that of healthy controls by sampling the tissue and uterine fluid with an endometrial biopsy and uterine lavage before and after IUD placement.   Specific inflammatory markers were tested, including markers of type 1 and type 2 macrophages, which have been linked to pro-inflammatory and anti-inflammatory states, respectively.   
We enrolled women between 18-45 years of age desiring intrauterine device insertion with a 1:2 ratio of healthy to stable solid organ transplant patient. At the first visit, the patient received a lab draw, uterine lavage and endometrial biopsy followed by intrauterine device insertion.  Follow-up visit was 30-45 days later for a repeat uterine lavage and endometrial biopsy.  Cytokine levels were measured in the uterine lavage and serum by quantifying inflammatory biomarkers. Immunohistochemistry staining was performed on the endometrial tissue to measure macrophage levels.  Statistical analysis noted any difference in the median changes of the inflammatory markers.  Bleeding diaries were also completed and an exit survey was given upon study completion.  
Findings from the study include no statistically significant changes in the serum levels of cytokines or soluble receptors in either groups after device insertion.  However, in the uterine lavage, there was an increase in cytokine levels after device insertion. For the endometrial tissue, there was evidence of macrophage activity in both groups after device insertion.  Findings from this study have pointed to the strong local inflammatory response following intrauterine device insertion for the transplant recipients in addition to the healthy controls.  In addition, bleeding profiles in both groups were comparable and satisfaction towards the IUD was high, especially among the transplant patient group. These preliminary findings will help power a larger study that can look into the safety and effectiveness of the IUD in this special patient population.

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