NCT02399787

Brief Summary

The aim of the post doc project is investigate which genes regulate implantation in order to analyze specific proteins and microRNA in the spent culture media with the long-term goal of developing a non-invasive method of embryo assessment and selection. This will be achieved by conducting a targeted NGS analysis, based on list obtained from a non-published pilot study. When further validated by q-PCR, the expression of specific microRNAs known to influence the final list of genes will be analyzed in the spent culture media and the protein products of the genes recovered from the media will be quantified. The level of specific microRNAs and proteins will be related to aneuploidy and implantation potential. If the level of specific microRNA and/or proteins correlates with pregnancy, the study will form the basis for developing a clinical applicable precise method of improved embryo selection and thus improved IVF treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

5.1 years

First QC Date

March 23, 2015

Last Update Submit

November 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • gene expression

    the expression of specific microRNAs known to influence the final list of genes will be analyzed in the spent culture media and the protein products of the genes recovered from the media will be quantified. The level of specific microRNAs and proteins will be related to aneuploidy and implantation potential. If the level of specific microRNA and/or proteins correlates with pregnancy, the study will form the basis for developing a clinical applicable precise method of improved embryo selection and thus improved IVF treatment

    2 years

Study Arms (1)

infertile patients

Infertile patients with more than 5 oocytes retrieved and no endometriosis

Other: blastocyst biopsy

Interventions

Performed on day 5

infertile patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infertile women

You may qualify if:

  • \>5 oocytes retrieved

You may not qualify if:

  • endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fertility Clinic, Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post doc

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations