Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women

January 29, 2017 updated by: University of Aarhus
The aim of this study is to evaluate the gene expression of the endometrium after an endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day LH+7.

Tissue is analysed and compared for changes in gene expression profile using Seq RNA

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

  • Denmark
      • Horsens, Denmark
        • Fertility Clinic Horsens Hospital

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Fertile women
  • Age: 18-40 years
  • BMI: 18-32
  • Regular menstrual cycle
  • No use of hormonal contraceptives or IUD the last 3 months

Exclusion Criteria:

  • Patients in need of a interpreter
  • Suspected intrauterine abnormalities
  • Pregnancy

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: endometrial biopsy
Procedure: endometrial biopsy
Other Names:
  • Pipelle de Cornier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene Expression of the Endometrium after an endometrial biopsy
Time Frame: 1 month between each biopsy

An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day LH+7.

Endometrial tissue is analysed for changes in gene expression profile of various chemokines and cytokines using RNA Sequencing technology
1 month between each biopsy

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Mia Steengaard Olesen, MD, Fertility Clinic Horsens Hospital, Aarhus University
  • Study Director: Axel Forman, MD, DMsc, Departement of Gynaecology and Obstetrics, Aarhus 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

June 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 29, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Miacol-2014-2H

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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