Selection of Embryos by Time-lapse

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01138631
First received: June 4, 2010
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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 Intervention
Infertility
Device: Embryoscope

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Selection of Embryos for IVF Treatment by Time-lapse

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 4-cell rate [ Time Frame: 2 days after oocyte pick-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Embryoscope Device: Embryoscope
The embryoscope is an incubator with in-built photographic equipment
No Intervention: Conventional incubator Device: Embryoscope
The embryoscope is an incubator with in-built photographic equipment

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.

  Eligibility

Ages Eligible for Study:   up to 37 Years
Genders 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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Professor Jakob Ingerslev, Fertility Clinic, Aarhus University Hospital, Skejby
ClinicalTrials.gov Identifier: NCT01138631     History of Changes
Other Study ID Numbers: 25940, 25940
Study First Received: June 4, 2010
Last Updated: May 9, 2011
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on October 20, 2014