NCT03445923

Brief Summary

All patients starting an IVF-treatment at the clinics, and meeting the inclusion criteria, will be offered to participate in the study. Randomization will be performed on day 5 and the patients will be allocated into either morphology only group or time-lapse group. Embryos will be cultured to day five according to the clinics own routines. All embryos in both groups will be cultured using time-lapse incubation. In the control group the embryo selection will be based only on traditional morphological evaluation and in the treatment group a time-lapse selection model (KID Score day 5) will be used to select the embryo.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
776

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
3 countries

11 active sites

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

First Submitted

Initial submission to the registry

February 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 29, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

3.1 years

First QC Date

February 20, 2018

Last Update Submit

October 13, 2021

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy (week 6-7)

    A confirmed pregnancy by ultrasound in the 6-7th week of gestation.

    Patient is assessed 6-7 weeks after embryo transfer

Secondary Outcomes (3)

  • Positive pregnancy tests, 18 days after embryo transfer.

    Patient is assessed 2 weeks after embryo transfer by taking a pregancy test

  • Early pregnancy loss (positive pregnancy test but no gestational sac observed at sonography)

    Same time frame as for the primary outcome i.e. 6-7 weeks.

  • Correlation between the preliminary decisions of embryo fate based only on morphology and the final decision made by time-lapse

    Can be made on the day of transfer (1 hour between primary and seconday decision).

Study Arms (2)

Morphology

NO INTERVENTION

Embryos for transfer will be selected based on standard morphological evaluation.

TLM

ACTIVE COMPARATOR

Embryos for transfer will be selected base on standard morphological evaluation and information from time-lapse monitoring.

Other: Time lapse monitoring (KID Score)

Interventions

Time lapse monitoring (KID Score)OTHER

The unique information that is obtainable from taking Pictures each 10 minutes throughout the development of the embryos will be used in the form of a special score (KID score). The score is comprised out of several key developmental parameters.

TLM

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • The couple shall receive and sign written information about the study.
  • On day 5, before the randomization the couple must have at least 2 transferrable blastocysts in order to be included in the study.
  • If double embryo transfer, for any reason, is planned.
  • Prior participation in the study.
  • Pre-implantation genetic diagnosis (PGD) treatment.
  • Embryo transfer on another day than day 5.
  • Oocyte cryopreservation.
  • Planned total freeze of embryos for any reason (cancer, OHSS etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Livio Reykjavik

Reykjavik, Iceland

Location

Livio Oslo

Oslo, Norway

Location

Livio Falun

Falun, Sweden

Location

Fertilitetscentrum Livio Göteborg

Gothenburg, Sweden

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

Livio Malmö

Malmo, Sweden

Location

Karolinska Universtetssjukhuset

Stockholm, Sweden

Location

Livio Gärdet

Stockholm, Sweden

Location

Livio Kungsholmen

Stockholm, Sweden

Location

Sophiahemmet

Stockholm, Sweden

Location

Livio Umeå

Umeå, Sweden

Location

Related Publications (1)

  • Ahlstrom A, Lundin K, Lind AK, Gunnarsson K, Westlander G, Park H, Thurin-Kjellberg A, Thorsteinsdottir SA, Einarsson S, Astrom M, Lofdahl K, Menezes J, Callender S, Nyberg C, Winerdal J, Stenfelt C, Jonassen BR, Oldereid N, Nolte L, Sundler M, Hardarson T. A double-blind randomized controlled trial investigating a time-lapse algorithm for selecting Day 5 blastocysts for transfer. Hum Reprod. 2022 Apr 1;37(4):708-717. doi: 10.1093/humrep/deac020.

    PMID: 35143661DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Laboratory Director

Study Record Dates

First Submitted

February 20, 2018

First Posted

February 26, 2018

Study Start

May 29, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

IC(1)NO(1)SE(9)