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Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility

NCT03401918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-04-01

Study results available
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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.

Conditions

  • Recurrent Pregnancy Loss
  • Unexplained Infertility

Interventions

DIAGNOSTIC_TEST

Uterine ERA and microbiome testing

Uterine fluid and endometrial biopsy collection to test uterine endometrial receptivity array and microbiome.

DRUG

Oral antibiotics and vaginal probiotics

For subjects with abnormal microbiome results, oral antibiotics and vaginal probiotic treatment will be offered followed by a repeat uterine microbiome biopsy.

Sponsors & Collaborators

  • Instituto Valenciano de Infertilidad, IVI VALENCIA

    collaborator OTHER

  • Stanford University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2021-07-01
Completion
2021-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03401918 on ClinicalTrials.gov