NCT03042364

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

January 31, 2017

Last Update Submit

March 15, 2018

Conditions

Infertility, Female

Keywords

Endometrium, Cytokines, Endometrial secretion, Implantation, Endometrial scratching

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

No intervention

NO INTERVENTION

Standard treatment

Intervention

EXPERIMENTAL

Endometrial scratching before standard treatment

Other: Pipelle de Cornier

Interventions

Pipelle de CornierOTHER

RCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day

Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Suspected intrauterine abnormalities Planned use of specialized media or AHA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fertility Clinic,Aalborg University Hospital

Aalborg, Denmark

Location

Fertility Clinic, Herlev Hospital

Herlev, Denmark

Location

Fertility Clinic Horsens Hospital

Horsens, Denmark

Location

Fertility Clinic, Skive Hospital

Skive, Denmark

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 3, 2017

Study Start

October 1, 2016

Primary Completion

March 14, 2018

Study Completion

March 14, 2018

Last Updated

March 16, 2018

Record last verified: 2018-03

Locations

DK(4)