Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility

Trial ID or NCT#

NCT03401918

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Exclusion Criteria:
  1. 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

Investigator(s)

Ruth Lathi, M.D.
Ruth Lathi, M.D.
Obstetrician and Gynecologist (OB-GYN), Fertility specialist
Professor of Obstetrics and Gynecology (Reproductive Endocrinology and Infertility)

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Contact

Sara J Churchill, MD
617-513-4997