Back to resultsGene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
endometrial biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Infertility, Endometrium, Endometrial biopsy, Gene expression
Eligibility 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
Sites / Locations
- Fertility Clinic Horsens Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
endometrial biopsy
Arm Description
Outcomes
Primary Outcome Measures
Gene Expression of the Endometrium after an endometrial 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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02219425
Brief Title
Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women
Official Title
Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Endometrium, Endometrial biopsy, Gene expression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endometrial biopsy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
endometrial biopsy
Other Intervention Name(s)
Pipelle de Cornier
Primary Outcome Measure Information:
Title
Gene Expression of the Endometrium after an endometrial biopsy
Description
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
Time Frame
1 month between each biopsy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Forman, MD, DMsc
Organizational Affiliation
Departement of Gynaecology and Obstetrics, Aarhus University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mia Steengaard Olesen, MD
Organizational Affiliation
Fertility Clinic Horsens Hospital, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Clinic Horsens Hospital
City
Horsens
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women
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