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Selection of Embryos by Time-lapse

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Embryoscope
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infertility focused on measuring IVF, Infertility, embryo selection, embryoscope, time-lapse

Eligibility Criteria

undefined - 37 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fertility Clinic, Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Embryoscope

Conventional incubator

Arm Description

Outcomes

Primary Outcome Measures

4-cell rate

Secondary Outcome Measures

Full Information

First Posted
June 4, 2010
Last Updated
March 30, 2017
Sponsor
University of Aarhus
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01138631
Brief Title
Selection of Embryos by Time-lapse
Official Title
Selection of Embryos for IVF Treatment by Time-lapse
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, Infertility, embryo selection, embryoscope, time-lapse

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Embryoscope
Arm Type
Active Comparator
Arm Title
Conventional incubator
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Embryoscope
Intervention Description
The embryoscope is an incubator with in-built photographic equipment
Primary Outcome Measure Information:
Title
4-cell rate
Time Frame
2 days after oocyte pick-up

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Ingerslev, DMSc
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Clinic, Aarhus University Hospital, Skejby
City
Aarhus
Country
Denmark

12. IPD Sharing Statement

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Selection of Embryos by Time-lapse

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