- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02554539
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
-
-
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
|
Patient will undergo a biopsy to aspirate endometrial fluid from the uterine cavity
|
Experimental: Normal weight
Women, aged 21-45 with BMI < 25
|
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
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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