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

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ClinicalTrials.gov Identifier: NCT02219425
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: endometrial biopsy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women
Study Start Date : June 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
endometrial biopsy Procedure: endometrial biopsy
Other Name: Pipelle de Cornier




Primary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219425


Locations
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Denmark
Fertility Clinic Horsens Hospital
Horsens, Denmark
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Axel Forman, MD, DMsc Departement of Gynaecology and Obstetrics, Aarhus University
Principal Investigator: Mia Steengaard Olesen, MD Fertility Clinic Horsens Hospital, Aarhus University
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02219425    
Other Study ID Numbers: Miacol-2014-2H
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: August 2016
Keywords provided by University of Aarhus:
Infertility
Endometrium
Endometrial biopsy
Gene expression
Additional relevant MeSH terms:
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Infertility