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Identification of Viable Human Embryos Using Three Different Methods

This study is currently recruiting participants.
Verified March 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01139268
First received: June 7, 2010
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

Infertility affects an increasing number of couples. For many, the choice of treatment is in vitro fertilization (IVF) . Currently, there are no markers fully predictive of developmental competence of IVF embryos. Present embryo selection is based on morphology assessment, which produces implantation rates in the range of 20%-30 %. The overall purpose of the present study is to investigate methods for selection of the best embryo. We aim to examine the relationship between pregnancy outcome and the transcriptional profile of selected genes, cleavage kinetics (time-lapse), and metabolic profile. We hypothesise that the quality of the embryo is reflected by the transcription of selected genes, the cleavage kinetics, and the metabolic profile. If so, these parameters can predict the success or failure of a pregnancy. Furthermore, the interrelationship - if any - between these parameters will be evaluated.

A secondary aim is to evaluate the effect of blastomere biopsy using time-lapse and metabolic analysis


Condition
Infertility

Study Type: Observational
Official Title: Examination of Gene Expression, Time-lapse and Near-infrared Spectroscopy (NIR) to Identify Differences in Embryo Viability

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • implantation/clinical pregnancy confirmed with pregnancy test and ultrasound [ Time Frame: 8 weeks after embryo transfer ] [ Designated as safety issue: No ]
    measurement of urine-hCG and vaginal ultrasound scan to evaluate pregnant/not pregnant


Secondary Outcome Measures:
  • gene expression quantified with Q-PCR [ Time Frame: within 6 months after biopsy and embryo transfer ] [ Designated as safety issue: No ]
    RT-Q-PCR analysis of selected genes

  • Metabolic profile using NIR analysis [ Time Frame: within 6 months after collection ] [ Designated as safety issue: No ]
    Near Infrared Spectroscopy (NIR) of the spent culture media. The spectral profile is used to calculate a viability index

  • cleavage kinetics [ Time Frame: before embryo transfer, during culturing ] [ Designated as safety issue: No ]
    imaging of the developing embryos during culturing. Data analysis concerning morphological parametres within 6 months after embryo transfer


Biospecimen Retention:   Samples With DNA

biopsies from human embryos


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women undergoing ART treament with single embryo transfer at the Fertility clinic, Aarhus University hospital Skejby, due to infertility,

Criteria

Inclusion Criteria:

  • age < 38 years
  • > 8 retrieved oocytes in present cycle or > 6 fertilized.

Exclusion Criteria:

  • endometriosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139268

Contacts
Contact: Kirstine Kirkegaard, MD kirstine.kirkegaard@ki.au

Locations
Denmark
The Fertility Clinic, Aarhus University Hospital, Skejby Recruiting
Aarhus, Denmark, 8200
Contact: Kirstine Kirkegaard, MD     +89426396     kirstine.kirkegaard@ki.au.dk    
Fertility Clinic, Aarhus University Hospital Skejby Not yet recruiting
Aarhus N, Denmark, 8200
Contact: kirstine kirkegaard, MD         kirstine.kirkegaard@ki.au.dk    
Principal Investigator: jakob Ingerslev, MD, DMsc            
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Jakob Ingerslev, MD, DMsc Fertility Clinic, Aarhus University Hospital, Skejby
Principal Investigator: kirstine Kirkegaard, MD Fertility Clinic, Aarhus University Hospital, Skejby
Principal Investigator: Johnny Hindkjær, DM.Sc. Fertility Clinic, Aarhus University Hospital, Skejby
Principal Investigator: Birte Degn, DmSc. PhD Fertility Clinic, Aarhus University Hospital, Skejby
Principal Investigator: Karin Lykke-Hartmann, DmSc, PhD Aarhus University, Department of Medical Biochemistry
Principal Investigator: Steen Koelvraa, MD, DMSc Department of Clinical Genetics, Vejle Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01139268     History of Changes
Other Study ID Numbers: M-20090241
Study First Received: June 7, 2010
Last Updated: March 20, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
embryo viability

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 17, 2013