Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility
Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility
The purpose of this study is to determine if patients with recurrent pregnancy loss or
 unexplained infertility have an altered uterine gene expression or uterine microbiome
 (micro-organism composition) during the window of embryo implantation. Furthermore we would
 like to assess for women with an abnormal uterine gene expression whether vaginal
 progesterone medication improves or alters gene expression and for women with an abnormal
 microbiome whether antibiotic treatment followed by probiotic treatment normalizes the
 microbiome.
Recurrent pregnancy loss and unexplained infertility are emotional and difficult diagnoses.
 Despite a thorough medical investigation, many cases of recurrent pregnancy loss and
 infertility remain unexplained. Understanding endometrial factors that may contribute to
 these diseases may lead to improved treatment options in the future. The purpose of this
 study is to determine if patients with recurrent pregnancy loss or unexplained infertility
 have an altered uterine gene expression or uterine microbiome (micro-organism composition)
 during the window of embryo implantation. Furthermore we would like to assess for women with
 an abnormal uterine gene expression whether vaginal progesterone medication improves or
 alters gene expression and for women with an abnormal microbiome whether antibiotic treatment
 followed by probiotic treatment normalizes the microbiome.

 A standard evaluation for infertility includes a uterine cavity evaluation, evaluation for
 ovarian reserve testing, and for patients with recurrent pregnancy loss parental testing for
 uterine infection, chromosome analysis, autoimmune and thyroid screening. This standard
 workup, however, does not include a molecular or microbial assessment of the endometrium.
 Endometrial factors may contribute to unexplained infertility or recurrent pregnancy loss
 however the extent of this is unknown.

 We are recruiting patients who have recurrent pregnancy loss, unexplained infertility, and
 healthy control patients who have had a term delivery in order to compare differences between
 these groups.

 Subjects will undergo an endometrial biopsy that will specifically test the receptivity of
 your endometrium as well as identify the bacterial composition of the uterine environment
 (microbiome). The endometrial receptivity array and microbiome testing will be performed at
 no cost. The endometrial receptivity array provides information on the receptivity of a
 patient's endometrium to the implantation of an embryo. This may yield additional information
 regarding the etiology of a patient's infertility and/or recurrent pregnancy loss. If this
 testing is abnormal we may repeat the biopsy after vaginal progesterone supplementation to
 see if this normalizes the results. If the microbiome is abnormal we may repeat the biopsy
 after oral antibiotics and vaginal probiotics to see if this normalizes your microbiome
 results.
Inclusion/Exclusion Criteria:

 1. Recurrent Pregnancy Loss

 Inclusion:

 -  Age 18-45

 -  3 or more SABs including biochemical pregnancies OR 2 or more SABs if one is
 documented to be euploid

 Exclusion:

 -  irregular menstrual cycles

 -  Submucosal fibroid >3cm

 -  Stage 3-4 endometriosis

 -  BMI >40

 -  IUD within the last 3 months

 2. Unexplained infertility Patients

 Inclusion:

 -  TTC x >= 1 year

 -  At least one SA with TMS >10 mil within last 2 years

 -  At least one patent fallopian tube documented by HSG or SHG

 -  Cycle length 25-35 days

 Exclusion:

 -  Irregular menstrual cycles

 -  Submucosal fibroid >3cm

 -  Stage 3-4 endometriosis

 -  BMI >40

 -  IUD within the last 3 months

 -  Less then 2 SABs including biochemical pregnancies

 3. Healthy control patients

 Inclusion:

 -  Patients who present for fertility preservation, sex selection, same sex couples
 needing fertility care, preconception counseling

 -  1 or more live births

 Exclusion:

 -  Irregular menstrual cycles

 -  Submucosal fibroid >3cm

 -  Stage 3-4 endometriosis

 -  BMI >40

 -  IUD within the last 3 months

 -  Less then 2 SABs including biochemical pregnancies

 -  No history of RPL or infertility