Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching

March 15, 2018 updated by: University of Aarhus
This study investigates the impact of endometrial scratching on endometrial secretion, when correlated to pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

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
      • Aalborg, Denmark
        • Fertility Clinic,Aalborg University Hospital
      • Herlev, Denmark
        • Fertility Clinic, Herlev Hospital
      • Horsens, Denmark
        • Fertility Clinic Horsens Hospital
      • Skive, Denmark
        • Fertility Clinic, Skive 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

No

Genders Eligible for Study

Female

Description

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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 12 months
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
Within 12 months

Collaborators and Investigators

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

Sponsor

University of Aarhus

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 (Actual)

October 1, 2016

Primary Completion (Actual)

March 14, 2018

Study Completion (Actual)

March 14, 2018

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Miacol-2017-3H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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