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Identification of Viable Human Embryos Using Three Different Methods

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01139268
First Posted: June 8, 2010
Last Update Posted: July 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  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:


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

  Eligibility

Information from the National Library of Medicine

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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,
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • endometriosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139268


Locations
Denmark
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01139268     History of Changes
Other Study ID Numbers: M-20090241
First Submitted: June 7, 2010
First Posted: June 8, 2010
Last Update Posted: July 18, 2013
Last Verified: July 2013

Keywords provided by University of Aarhus:
embryo viability

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