Back to resultsCytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
Primary Purpose
Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pipelle de Cornier
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility, Female focused on measuring Endometrium, Cytokines, Endometrial secretion, Implantation, Endometrial scratching
Eligibility Criteria
Inclusion Criteria:
- IVF or ICSI patients with ≥1 previous implantation failure, despite transfer of a top quality embryo or blastocyst.
- Antagonist treatment
- FSH: 2-12 IU/L
- BMI: 18-32
- Regular menstrual cycle
- Written consent
Exclusion Criteria:
- Suspected intrauterine abnormalities Planned use of specialized media or AHA
Sites / Locations
- Fertility Clinic,Aalborg University Hospital
- Fertility Clinic, Herlev Hospital
- Fertility Clinic Horsens Hospital
- Fertility Clinic, Skive Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No intervention
Intervention
Arm Description
Standard treatment
Endometrial scratching before standard treatment
Outcomes
Primary Outcome Measures
Cytokine profile of the uterine secretome after therapeutic endometrial scratching
The secretome is analyzed using a Multiplex analysis with 45 cytokines, chemokines and growth factors from ProcartaPlex Immunoassay Kit, Affymetrix, eBioscience. The samples are normalized for total protein content using a Nanodrop spectrophometer, and the protein composition is further determined by sodium dodecyl sulphate-polyacrylamide gel electropheresis (SDS-PAGE).
Immunoassay Kit:
BDNF, EGF, Eotaxin, FGF-2, GMCSF, GRO-alpha, HGF, IFN alpha, IFN gamma, IL-1RA, IL-1alpha, IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL17-A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1 alpha, MIP-1 beta, NGF beta, RANTES, PDGF-BB, PÅIGF-1, SCF, SDF-1 alpha, TNF alpha, TNF beta, VEGF-A, VEGF-D
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03042364
Brief Title
Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
Official Title
Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
March 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study investigates the impact of endometrial scratching on endometrial secretion, when correlated to pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Endometrium, Cytokines, Endometrial secretion, Implantation, Endometrial scratching
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Standard treatment
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Endometrial scratching before standard treatment
Intervention Type
Other
Intervention Name(s)
Pipelle de Cornier
Intervention Description
RCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day
Primary Outcome Measure Information:
Title
Cytokine profile of the uterine secretome after therapeutic endometrial scratching
Description
The secretome is analyzed using a Multiplex analysis with 45 cytokines, chemokines and growth factors from ProcartaPlex Immunoassay Kit, Affymetrix, eBioscience. The samples are normalized for total protein content using a Nanodrop spectrophometer, and the protein composition is further determined by sodium dodecyl sulphate-polyacrylamide gel electropheresis (SDS-PAGE).
Time Frame
Within 12 months
Title
Immunoassay Kit:
Description
BDNF, EGF, Eotaxin, FGF-2, GMCSF, GRO-alpha, HGF, IFN alpha, IFN gamma, IL-1RA, IL-1alpha, IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL17-A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1 alpha, MIP-1 beta, NGF beta, RANTES, PDGF-BB, PÅIGF-1, SCF, SDF-1 alpha, TNF alpha, TNF beta, VEGF-A, VEGF-D
Time Frame
Within 12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IVF or ICSI patients with ≥1 previous implantation failure, despite transfer of a top quality embryo or blastocyst.
Antagonist treatment
FSH: 2-12 IU/L
BMI: 18-32
Regular menstrual cycle
Written consent
Exclusion Criteria:
Suspected intrauterine abnormalities Planned use of specialized media or AHA
Facility Information:
Facility Name
Fertility Clinic,Aalborg University Hospital
City
Aalborg
Country
Denmark
Facility Name
Fertility Clinic, Herlev Hospital
City
Herlev
Country
Denmark
Facility Name
Fertility Clinic Horsens Hospital
City
Horsens
Country
Denmark
Facility Name
Fertility Clinic, Skive Hospital
City
Skive
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
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