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Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching

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ClinicalTrials.gov Identifier: NCT03042364
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
This study investigates the impact of endometrial scratching on endometrial secretion, when correlated to pregnancy.

Condition or disease Intervention/treatment Phase
Infertility, Female Other: Pipelle de Cornier Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : March 14, 2018
Actual Study Completion Date : March 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No intervention
Standard treatment
Experimental: Intervention
Endometrial scratching before standard treatment
Other: Pipelle de Cornier
RCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day




Primary Outcome Measures :
  1. Cytokine profile of the uterine secretome after therapeutic endometrial scratching [ Time Frame: Within 12 months ]
    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).

  2. Immunoassay Kit: [ Time Frame: Within 12 months ]
    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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

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): NCT03042364


Locations
Denmark
Fertility Clinic,Aalborg University Hospital
Aalborg, Denmark
Fertility Clinic, Herlev Hospital
Herlev, Denmark
Fertility Clinic Horsens Hospital
Horsens, Denmark
Fertility Clinic, Skive Hospital
Skive, Denmark
Sponsors and Collaborators
University of Aarhus

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03042364     History of Changes
Other Study ID Numbers: Miacol-2017-3H
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Endometrium, Cytokines, Endometrial secretion, Implantation, Endometrial scratching

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female