Selection of Embryos by Time-lapse
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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 |
- 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 |
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| Denmark | |
| Fertility Clinic, Aarhus University Hospital, Skejby | |
| Aarhus, Denmark | |
| 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, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 22, 2013