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Status unknownNCT02222831Updated May 17, 2022

Optimizing IVF Treatment - the Impact of Time-lapse Culture and Preimplantation Factor (PIF) on Embryo Development.

An interventional study of Day 0 denudation and time lapse culture on IVF-oocytes. in In Vitro Fertilization and Assisted Reproductive Techniques, sponsored by Regionshospitalet Viborg, Skive. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by Regionshospitalet Viborg, Skive · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

The aims of this study are to evaluate:

  1. the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on fertilisation rates and embryo quality in standard IVF.
  2. the association between PIF status in embryo culture medium and embryo quality assessed by standard subjective parameters and morphokinetic development.
02

Conditions studied

  • In Vitro Fertilization
  • Assisted Reproductive Techniques

Keywords

  • IVF
  • Embryo Quality
  • Time Lapse Culture
  • Preimplantation factor
03

In context

Lead sponsor

Regionshospitalet Viborg, Skive is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Standard IVF treatment
  • Body mass Index (BMI) between 18 and 30
  • couples in which the male partner has normal sperm concentration and motility according to the World Health Organization (WHO, 2010)

Exclusion criteria

Exclusion Criteria:

  • Patients with less than four oocytes
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Day 0 - Study arm

    Day 0 denudation and time lapse culture on IVF-oocytes.: After insemination the oocytes will subsequently be denuded and cultured in the EmbryoScope (day 0). The embryo culture media will be collected at day 2-5.

    Procedure: Day 0 denudation and time lapse culture on IVF-oocytes.

  • No intervention
    Day 1 - control arm

    After insemination oocytes in the control group will be incubated in a standard incubator overnight. On day 1 the oocytes in the will be denuded and further cultured in the EmbryoScope. The embryo culture media will be collected at day 2-5.

Interventions

  • ProcedureDay 0 denudation and time lapse culture on IVF-oocytes.
06

What researchers measure

Primary outcomes

  1. Embryo Quality

    Time frame: Day 0-5 after oocyte pick-up

Secondary outcomes

  1. Fertilisation rate

    Time frame: Day 1 after oocyte pick-up

Other outcomes

  1. Clinical pregnancy rate

    Time frame: 7th week of gestation

07

Study locations

1 site
  • The Fertility Clinic Skive
    Skive, 7800, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02222831
Lead sponsor
Regionshospitalet Viborg, Skive
Responsible party
Betina Boel Povlsen, MSc (MSc, Laboratory Director, The Fertility Clinic Skive; Denmark., Regionshospitalet Viborg, Skive) — Principal investigator
First posted
Aug 21, 2014
Start date
Jun 2014
Primary completion
Jan 2016
Completion
Dec 2022 (estimated)
Last update
May 17, 2022

Study contacts

Betina B Povlsen, MSc
principal investigator · The Fertility Clinic, Skive Regional Hospital, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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