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

NCT02222831 | Unknown

• 1 other identifier: Skive-2014-BBP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to evaluate:

1. 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. 2.the association between PIF status in embryo culture medium and embryo quality assessed by standard subjective parameters and morphokinetic development.

Conditions

In Vitro Fertilization; Assisted Reproductive Techniques

Keywords

IVF; Embryo Quality; Time Lapse Culture; Preimplantation factor

Outcome Measures

Primary Outcomes (1)

• Embryo Quality

  Day 0-5 after oocyte pick-up

Secondary Outcomes (1)

• Fertilisation rate

  Day 1 after oocyte pick-up

Other Outcomes (1)

• Clinical pregnancy rate

  7th week of gestation

Study Arms (2)

Day 0 - Study arm

EXPERIMENTAL

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.

Day 1 - control arm

NO INTERVENTION

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

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

Day 0 - Study arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• \- Patients with less than four oocytes

Sponsors & Collaborators

• Regionshospitalet Viborg, Skive: lead

Study Sites (1)

The Fertility Clinic Skive

Skive, 7800, Denmark

Location

Study Officials

• Betina B Povlsen, MSc

  The Fertility Clinic, Skive Regional Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Laboratory Director, The Fertility Clinic Skive; Denmark.

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 21, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

DK (1)