Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching

Infertility, Female Clinical Trial

Official title:

Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042364
• Other study ID #: Miacol-2017-3H
• Status: Completed
• Phase: N/A
• First received: January 31, 2017
• Last updated: March 15, 2018
• Start date: October 1, 2016
• Est. completion date: March 14, 2018

Study information

• Verified date: March 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 14, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Other:
• Pipelle de Cornier
RCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Within 12 months
Primary	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	Within 12 months