Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

NCT ID: NCT01773603

Last Updated: 2013-01-23

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

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-07-31

Brief Summary

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Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion.

This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Conventional incubation

Five-day embryo culture in conventional incubators

Group Type NO_INTERVENTION

No interventions assigned to this group

Embryoscope

Five-day embryo culture in embryoscope which is an incubator with a built-in camera

Group Type ACTIVE_COMPARATOR

Embryoscope

Intervention Type DEVICE

Five-day embryo culture in embryoscope which is an incubator with a built-in camera

Interventions

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Embryoscope

Five-day embryo culture in embryoscope which is an incubator with a built-in camera

Intervention Type DEVICE

Other Intervention Names

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Time-lapse monitoring of human embryos in Embryoscope

Eligibility Criteria

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Inclusion Criteria

* patients in their first or second ART treatment cycle
* no recurrent spontaneous abortions
* age\<35 years
* BMI\<28 kg/m2
* ≥8 oocytes retrieved

Exclusion Criteria

* severe endometriosis
* polycystic ovary syndrome
* hydrosalpynx
* uterine pathology
* severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)
* very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Murat Çetinkaya

OTHER

Sponsor Role lead

Responsible Party

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Dr. Murat Çetinkaya

R&D Laboratory Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Semra Kahraman, MD, Prof

Role: STUDY_DIRECTOR

Sisli Memorial Hospital

Locations

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Sisli Memorial Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IMH2013-1

Identifier Type: OTHER

Identifier Source: secondary_id

MC0405

Identifier Type: -

Identifier Source: org_study_id

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