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
Intervention: Uterine ERA and microbiome testing; Oral antibiotics and vaginal probiotics
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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