NCT02372279

Brief Summary

In a conventional in vitro fertilization (IVF) cycle, daily microscopic observation of embryos outside the incubator to assess their morphology and establish a selection process is performed. In this way it is possible to know which embryo or embryos have greater implantantion capacity and will be transferred to the uterus to obtain a viable pregnancy. However, these observations can produce deleterious effects on embryo development due to changes in temperature, pH and osmolarity of the culture media, as well as a negative effect of direct light microscope for observation. This project aims to test the hypothesis that non-embryonic observation produces a beneficial effect on embryo quality until day 5 of development (blastocyst stage) and, therefore, on rates of implantation and ongoing gestation, compared with the conventional protocol of observations under the inverted microscope on days two, three and five of development.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

6.1 years

First QC Date

February 20, 2015

Last Update Submit

June 21, 2021

Conditions

Placenta; Implantation

Keywords

Embryo developmentImplantationIn vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • Live Birth Rate

    The number of deliveries that resulted in a live born neonate, expressed per 100 embryos

    Nine months after treatment.

Secondary Outcomes (8)

  • Positive hCG rate

    14 days after oocyte retrieval.

  • Implantation rate

    6-7 weeks after oocyte retrieval.

  • Ongoing pregnancy rate

    12 weeks after B-hCG positive test

  • Miscarriage rate

    From 12 weeks after gestation to delivery

  • Fertilization rate

    16-18 hours after microinjection or insemination

  • +3 more secondary outcomes

Study Arms (2)

No embryo observation (NEO)

NO INTERVENTION

Study group. No embryonic observation from day one to day five of embryo development.

Embryo observation (EO)

EXPERIMENTAL

Control group. Conventional embryonic observations performed in day two, three and five of embryo development.

Other: Embryo observation

Interventions

Embryo observationOTHER

In EO group, conventional observations will be made.

Embryo observation (EO)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First cycle of ART treatment with conventional IVF or ICSI with donated eggs.
  • Normal uterine cavity and a single or double embryo transfer, always performed on day 5 at blastocyst stage.

You may not qualify if:

  • Patients above 50 years old, patients that were diagnosed with recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL) or uterine pathologies,
  • Body mass index \>30 kg/m2.
  • The use of seminal samples coming from donors or testicular origin.
  • Cycles that included preimplantational genetic testing (PGT).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Bernabeu

Alicante, 03016, Spain

Location

Related Publications (12)

  • Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.

    PMID: 21502182BACKGROUND

  • Fujiwara M, Takahashi K, Izuno M, Duan YR, Kazono M, Kimura F, Noda Y. Effect of micro-environment maintenance on embryo culture after in-vitro fertilization: comparison of top-load mini incubator and conventional front-load incubator. J Assist Reprod Genet. 2007 Jan;24(1):5-9. doi: 10.1007/s10815-006-9088-3. Epub 2006 Dec 13.

    PMID: 17160731BACKGROUND

  • Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.

    PMID: 10856474BACKGROUND

  • Bernabeu R, Roca M, Torres A, Ten J. Indomethacin effect on implantation rates in oocyte recipients. Hum Reprod. 2006 Feb;21(2):364-9. doi: 10.1093/humrep/dei343. Epub 2005 Nov 10.

    PMID: 16284067BACKGROUND

  • Herrero J, Tejera A, Albert C, Vidal C, de los Santos MJ, Meseguer M. A time to look back: analysis of morphokinetic characteristics of human embryo development. Fertil Steril. 2013 Dec;100(6):1602-9.e1-4. doi: 10.1016/j.fertnstert.2013.08.033. Epub 2013 Sep 29.

    PMID: 24083877BACKGROUND

  • Zhang JQ, Li XL, Peng Y, Guo X, Heng BC, Tong GQ. Reduction in exposure of human embryos outside the incubator enhances embryo quality and blastulation rate. Reprod Biomed Online. 2010 Apr;20(4):510-5. doi: 10.1016/j.rbmo.2009.12.027. Epub 2009 Dec 28.

    PMID: 20129824BACKGROUND

  • Kirkegaard K, Kesmodel US, Hindkjaer JJ, Ingerslev HJ. Time-lapse parameters as predictors of blastocyst development and pregnancy outcome in embryos from good prognosis patients: a prospective cohort study. Hum Reprod. 2013 Oct;28(10):2643-51. doi: 10.1093/humrep/det300. Epub 2013 Jul 30.

    PMID: 23900207BACKGROUND

  • Steptoe PC, Edwards RG. Birth after the reimplantation of a human embryo. Lancet. 1978 Aug 12;2(8085):366. doi: 10.1016/s0140-6736(78)92957-4. No abstract available.

    PMID: 79723BACKGROUND

  • Bognar Z, Csabai TJ, Pallinger E, Balassa T, Farkas N, Schmidt J, Gorgey E, Berta G, Szekeres-Bartho J, Bodis J. The effect of light exposure on the cleavage rate and implantation capacity of preimplantation murine embryos. J Reprod Immunol. 2019 Apr;132:21-28. doi: 10.1016/j.jri.2019.02.003. Epub 2019 Mar 4.

    PMID: 30852462BACKGROUND

  • Barberet J, Chammas J, Bruno C, Valot E, Vuillemin C, Jonval L, Choux C, Sagot P, Soudry A, Fauque P. Randomized controlled trial comparing embryo culture in two incubator systems: G185 K-System versus EmbryoScope. Fertil Steril. 2018 Feb;109(2):302-309.e1. doi: 10.1016/j.fertnstert.2017.10.008. Epub 2017 Nov 23.

    PMID: 29175066BACKGROUND

  • Armstrong S, Bhide P, Jordan V, Pacey A, Marjoribanks J, Farquhar C. Time-lapse systems for embryo incubation and assessment in assisted reproduction. Cochrane Database Syst Rev. 2019 May 29;5(5):CD011320. doi: 10.1002/14651858.CD011320.pub4.

    PMID: 31140578BACKGROUND

  • Kalleas D, McEvoy K, Horne G, Roberts SA, Brison DR. Live birth rate following undisturbed embryo culture at low oxygen in a time-lapse incubator compared to a high-quality benchtop incubator. Hum Fertil (Camb). 2022 Feb;25(1):147-153. doi: 10.1080/14647273.2020.1729423. Epub 2020 Feb 26.

    PMID: 32098536BACKGROUND

Study Officials

  • Jorge Ten Morro, Ph.D.

    Instituto Bernabeu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Embryologist

Study Record Dates

First Submitted

February 20, 2015

First Posted

February 26, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations

ES(1)