Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT03042364
• Collaborator: (none)
• Enrollment: 150
• Locations: 4
• Arms: 2
• Actual Duration (Months): 17.4
• Patients Per Site: 37.5
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized clinical trialRandomized 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: Oct 1, 2016
• Actual Primary Completion Date: Mar 14, 2018
• Actual Study Completion Date: Mar 14, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cytokine profile of the uterine secretome after therapeutic endometrial scratching [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: [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fertility Clinic,Aalborg University Hospital	Aalborg		Denmark
2	Fertility Clinic, Herlev Hospital	Herlev		Denmark
3	Fertility Clinic Horsens Hospital	Horsens		Denmark
4	Fertility Clinic, Skive Hospital	Skive		Denmark

Sponsors and Collaborators

• University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT03042364
• Other Study ID Numbers: Miacol-2017-3H
• First Posted: Feb 3, 2017
• Last Update Posted: Mar 16, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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

Study Results

No Results Posted as of Mar 16, 2018