Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility
Condition: Recurrent Pregnancy Loss; Unexplained Infertility
MeSH terms: Infertility; Abortion, Spontaneous; Fetal Death; Abortion, Habitual; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Uterine ERA and microbiome testing; Oral antibiotics and vaginal probiotics
Intervention type(s): Diagnostic Test; Drug
Intervention description(s): Uterine fluid and endometrial biopsy collection to test uterine endometrial receptivity array and microbiome.; For subjects with abnormal microbiome results, oral antibiotics and vaginal probiotic treatment will be offered followed by a repeat uterine microbiome biopsy.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment