Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility

Not Recruiting

Trial ID: NCT03401918

Age - 18 Years-45 Years Gender - Female Accepting Healthy Volunteers - yes

Purpose

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.

Official Title

Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility

Stanford Investigator(s)

Ruth Lathi, M.D.
Ruth Lathi, M.D.

Professor of Obstetrics and Gynecology (Reproductive Endocrinology and Infertility)

Eligibility


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

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Intervention(s):

diagnostic test: Uterine ERA and microbiome testing

drug: Oral antibiotics and vaginal probiotics

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sara J Churchill, MD
617-513-4997

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