Transciptomic Modification Induced by miRNAs in Endometrial Fluid (miRNA_EF)

April 18, 2018 updated by: Meera Sridhar Shah, Stanford University

Human Embryonic Transciptomic Modification Induced by miRNAs Secreted by Human Endometrium to Endometrial Fluid

The purpose of this study is to understand the mechanism of communication between the uterine environment and the preimplantation human embryo. The investigators are interested in understanding how the in-utero environment during the window of implantation is different in normal weight and overweight/obese women and how this may impact the programming of the developing embryo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Meet the WHO criteria for normal weight (BMI < 25) and overweight/obese (BMI > 25)
  • Age 21-45

Exclusion Criteria:

  • Age < 21 or > 45
  • Women with history of hysterectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese
Women, aged 21-45 with BMI >30
Procedure: Endometrial fluid aspiration
Patient will undergo a biopsy to aspirate endometrial fluid from the uterine cavity
Experimental: Normal weight
Women, aged 21-45 with BMI < 25
Procedure: Endometrial fluid aspiration
Patient will undergo a biopsy to aspirate endometrial fluid from the uterine cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression profile in human embryos
Time Frame: Samples will be collected within 1 month of enrollment
We will perform RNA sequencing on the human embryo to quantify which genes are up and down regulated in obese compared to normal weight controls.
Samples will be collected within 1 month of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 34225

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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