Sunnyvale, California 94087

  • Unexplained Infertility

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.


Study summary:

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.


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


NCT ID:

NCT03401918


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Sunnyvale, California 94087
United States

Sara J Churchill, MD
Phone: 617-513-4997
Email: sarajc@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 17, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.