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

NCT ID: NCT02222831

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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In Vitro Fertilization Assisted Reproductive Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Regionshospitalet Viborg, Skive

OTHER

Sponsor Role lead

Responsible Party

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Betina Boel Povlsen, MSc

MSc, Laboratory Director, The Fertility Clinic Skive; Denmark.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Betina B Povlsen, MSc

Role: PRINCIPAL_INVESTIGATOR

The Fertility Clinic, Skive Regional Hospital, Denmark

Locations

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The Fertility Clinic Skive

Skive, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Skive-2014-BBP

Identifier Type: -

Identifier Source: org_study_id

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