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Identification of Viable Human Embryos Using Three Different Methods

This study has been completed.
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: June 7, 2010
Last updated: July 17, 2013
Last verified: July 2013

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


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:

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 ]
    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 ]
    RT-Q-PCR analysis of selected genes

  • Metabolic profile using NIR analysis [ Time Frame: within 6 months after collection ]
    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 ]
    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

Enrollment: 161
Study Start Date: June 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes 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,

Inclusion Criteria:

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

Exclusion Criteria:

  • endometriosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01139268

Fertility Clinic, Aarhus University Hospital Skejby
Aarhus N, Denmark, 8200
The Fertility Clinic, Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Aarhus Identifier: NCT01139268     History of Changes
Other Study ID Numbers: M-20090241
Study First Received: June 7, 2010
Last Updated: July 17, 2013

Keywords provided by University of Aarhus:
embryo viability

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on August 17, 2017