Selection of Embryos by Time-lapse

NCT ID: NCT01138631

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Embryoscope

Group Type ACTIVE_COMPARATOR

Embryoscope

Intervention Type DEVICE

The embryoscope is an incubator with in-built photographic equipment

Conventional incubator

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Embryoscope

The embryoscope is an incubator with in-built photographic equipment

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Fertility Clinic, Aarhus University Hospital, Skejby

Principal Investigators

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Jakob Ingerslev, DMSc

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Fertility Clinic, Aarhus University Hospital, Skejby

Aarhus, Aarhus, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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25940

Identifier Type: REGISTRY

Identifier Source: secondary_id

25940

Identifier Type: -

Identifier Source: org_study_id

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