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Selection of Embryos by Time-lapse

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ClinicalTrials.gov Identifier: NCT01138631
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
University of Aarhus

Brief Summary:

In order to improve success rate by assisted reproductive techniques new techniques are being developed for selection of the embryo with best chance of implantation, establishement of pregnancy and subsequent delivery.The present study is based upon the hypothesis that time-lapse (frequent imaging) may give information about important steps in embryonic development, which could help to optimize selection of embryo(s) for treatment in IVF. The present study evaluates the outcome of conventional embryo culture with culture in a specially developed incubator equipped with a time-lapse system (Embryoscope).

Embryos from 50 IVF cycles (400 embryos) will be randomised to either conventional incubation or to culture in the Embryoscope. Embryos will be cultured for five days to the blastocyst stage. The primary endpoint is fraction of embryos developed to the four cell stage.


Condition or disease Intervention/treatment Phase
Infertility Device: Embryoscope Not Applicable

Detailed Description:
In vitro fertilization for infertility has a success rate on average in Europe of 25% in terms of baby take-home rate per cycle. One way to improve this rather low succes rate is to develop new measures for selection of the best embryo among peers as presently evaluated by embryo morphology. One of these promising methods is contineous imaging of embryo development by time-lapse. A new and unique equipment for this purpose - an Embryoscope - har been developed by Unisense Fertilitech. The present study evaluates embryo 4-cell rate during cultivation to blastocyst stage in a conventional incubator with 4-cell rate in the Embryoscope to ensure non-inferiority of the latter.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Selection of Embryos for IVF Treatment by Time-lapse
Study Start Date : June 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Embryoscope Device: Embryoscope
The embryoscope is an incubator with in-built photographic equipment
No Intervention: Conventional incubator



Primary Outcome Measures :
  1. 4-cell rate [ Time Frame: 2 days after oocyte pick-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 37 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing 2.nd or 3.rd IVF cycle with expected retrieval of 8 oocytes or more. Age < 38 years

Exclusion Criteria:

  • Endometriosis

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): NCT01138631


Locations
Denmark
Fertility Clinic, Aarhus University Hospital, Skejby
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
University of Copenhagen
Investigators
Principal Investigator: Jakob Ingerslev, DMSc University of Aarhus

Responsible Party: Professor Jakob Ingerslev, Fertility Clinic, Aarhus University Hospital, Skejby
ClinicalTrials.gov Identifier: NCT01138631     History of Changes
Other Study ID Numbers: 25940
25940 ( Registry Identifier: Regional Ethics Comittee )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: May 2011

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
IVF, Infertility, embryo selection, embryoscope, time-lapse

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