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Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates

NCT ID: NCT02048527

Last Updated: 2014-12-16

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

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.

Detailed Description

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Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.

The current study will include 2 RCTs:

RCT 1: Random allocation of sibling oocytes to compare embryo development and blastocyst formation rates in the two culture media compared.

RCT2: Random allocation of patients in either Global or Origio media, to evaluate pregnancy rates.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Global

In vitro embryo culture in single-step medium (Global)

Group Type ACTIVE_COMPARATOR

Global

Intervention Type OTHER

Single medium for the culture of embryos from Day1 to Day 5

Origio

In vitro embryo culture in sequential media (Origio)

Group Type ACTIVE_COMPARATOR

Origio

Intervention Type OTHER

Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)

Interventions

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Global

Single medium for the culture of embryos from Day1 to Day 5

Intervention Type OTHER

Origio

Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)

Intervention Type OTHER

Other Intervention Names

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Global medium (LIfeGlobal) ISM1/BlastAssist (Origio)

Eligibility Criteria

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Inclusion Criteria

* \<40 years of age
* female infertility patients
* at least 10 retrieved oocytes

Exclusion Criteria

* 41 years or older
* frozen-thawed oocytes/embryos
* oocyte donation cycles
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eugonia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ioannis A Sfontouris, PhD

Role: PRINCIPAL_INVESTIGATOR

Eugonia

Trifon G Lainas, PhD

Role: STUDY_DIRECTOR

Eugonia

Locations

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Eugonia Assisted Reproduction Unit

Athens, Attica, Greece

Site Status

Countries

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Greece

References

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Sepulveda S, Garcia J, Arriaga E, Diaz J, Noriega-Portella L, Noriega-Hoces L. In vitro development and pregnancy outcomes for human embryos cultured in either a single medium or in a sequential media system. Fertil Steril. 2009 May;91(5):1765-70. doi: 10.1016/j.fertnstert.2008.02.169. Epub 2008 Apr 25.

Reference Type BACKGROUND
PMID: 18439587 (View on PubMed)

Basile N, Morbeck D, Garcia-Velasco J, Bronet F, Meseguer M. Type of culture media does not affect embryo kinetics: a time-lapse analysis of sibling oocytes. Hum Reprod. 2013 Mar;28(3):634-41. doi: 10.1093/humrep/des462. Epub 2013 Jan 12.

Reference Type BACKGROUND
PMID: 23315059 (View on PubMed)

Other Identifiers

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Global versus Origio

Identifier Type: -

Identifier Source: org_study_id