Embryo Selection by Time Lapse Monitoring for Single Embryo Transfer ("SET")

NCT01694641 | Terminated Phase 4 Results DMC

• 1 other identifier: TL-SET
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 2

Brief Summary

A multiple pregnancy is an undesired outcome of assisted reproduction. Current embryo selection technologies are inefficient in identifying the embryo with the highest implantation potential. Time lapse (TL) embryo monitoring provides additional information about embryo development and therefore may aid embryo selection. The investigators aim is to study whether TL monitoring is superior to traditional embryo observation when a single blastocyst is selected for transfer (ET).

Conditions

Clinical Pregnancy After Single Embryo Transfer

Keywords

time lapse monitoring; blastocyst; single embryo transfer; clinical pregnancy; implantation rate

Outcome Measures

Primary Outcomes (1)

• Pregnancy Rate

  rise in beta HCG 12-14 days after transfer

  12-14 days after transfer

Secondary Outcomes (1)

• Live Birth

  delivery after 24 weeks

Other Outcomes (2)

• Time Lapse Score

  the time lapse score is assessed on the day of embryo transfer (day 5 after the egg retrieval)

• Perinatal Outcome

  perinatal outcome assessed after delivery

Study Arms (2)

time-lapse morphokinetic evaluation

EXPERIMENTAL

Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos in a petri dish that allows individual assessment (Primo Vision Dish) are placed onto an automated time-lapse equipment in an incubator. The time-lapse equipment performs imaging in 10 minutes intervals. The software is presenting the up-to-date images and allows the operator to assess the "time-lapse" movie of the developmental history of the embryos to perform annotations and apply evaluation/selection algorithm. This morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection, which actually describes the intervention.

Other: time-lapse morphokinetic evaluation

standard embryo monitoring

NO INTERVENTION

Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.

Interventions

time-lapse morphokinetic evaluation OTHER

embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse

Also known as: time-lapse morphokintic score

time-lapse morphokinetic evaluation

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \< 36 yrs
• baseline FSH \<10 IU/l
• regular 25-35 day cycles
• less than 2 previous failed IVF cycles
• intact uterus
• an indication for IVF
• BMI \<18- \<30 kg/m2
• acceptance of single embryo transfer

You may not qualify if:

• PCOS
• Sperm obtained by surgical extraction
• chromosome abnormality
• Presence of hydrosalpinx
• stage III/IV endometriosis
• Less than 3 good quality day 3 embryos
• only one good quality day 5 embryos
• lack of consent

Sponsors & Collaborators

• Dunamenti REK Istenhegyi IVF Center: lead
• Forgacs Intezet Kft.: collaborator

Study Sites (2)

Kaali Institute IVF Center

Budapest, 1125, Hungary

Location

Forgacs Intezet

Budapest, 1205, Hungary

Location

Related Publications (3)

• Pribenszky C, Matyas S, Kovacs P, Losonczi E, Zadori J, Vajta G. Pregnancy achieved by transfer of a single blastocyst selected by time-lapse monitoring. Reprod Biomed Online. 2010 Oct;21(4):533-6. doi: 10.1016/j.rbmo.2010.04.015. Epub 2010 Apr 24.

  PMID: 20638906 BACKGROUND

• Pribenszky C, Losonczi E, Molnar M, Lang Z, Matyas S, Rajczy K, Molnar K, Kovacs P, Nagy P, Conceicao J, Vajta G. Prediction of in-vitro developmental competence of early cleavage-stage mouse embryos with compact time-lapse equipment. Reprod Biomed Online. 2010 Mar;20(3):371-9. doi: 10.1016/j.rbmo.2009.12.007. Epub 2010 Jan 25.

  PMID: 20089456 BACKGROUND

• Meseguer M, Herrero J, Tejera A, Hilligsoe KM, Ramsing NB, Remohi J. The use of morphokinetics as a predictor of embryo implantation. Hum Reprod. 2011 Oct;26(10):2658-71. doi: 10.1093/humrep/der256. Epub 2011 Aug 9.

  PMID: 21828117 BACKGROUND

Limitations and Caveats

The downside of the study demographics is that we limited the study population to good prognosis cases therefore the conclusions can only be applied to similar patients. Stopped the study before meeting calculated sample size.

Results Point of Contact

• Title: Dr Peter Kovacs
• Organization: Kaali Inst. IVF Center

peterkovacs1970@hotmail.com

36-1-202-2802

Study Officials

• Peter Kovacs, MD

  Kaali Inst. IVF Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 27, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 13, 2018
• Results First Posted: December 29, 2016

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2)