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

May 16, 2022 updated by: Betina Boel Povlsen, MSc, Regionshospitalet Viborg, Skive

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Skive, Denmark, 7800
        • The Fertility Clinic Skive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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:

- Patients with less than four oocytes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Embryo Quality
Time Frame: Day 0-5 after oocyte pick-up
Day 0-5 after oocyte pick-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Fertilisation rate
Time Frame: Day 1 after oocyte pick-up
Day 1 after oocyte pick-up

Other Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 7th week of gestation
7th week of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regionshospitalet Viborg, Skive

Investigators

  • Principal Investigator: Betina B Povlsen, MSc, The Fertility Clinic, Skive Regional Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 21, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Skive-2014-BBP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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