Embryo Development Using Two Commercial Single-step Media

NCT ID: NCT02302638

Last Updated: 2015-06-09

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

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

Brief Summary

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This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Embryos will be cultured continuously for up to 6 days under identical conditions.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sage 1-step

Embryo culture in different single-step media:

Half of each patient's oocytes will be randomly allocated to be cultured in Sage 1-step medium for up to six days following oocyte retrieval.

Group Type ACTIVE_COMPARATOR

embryo culture in different single-step media

Intervention Type OTHER

Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.

CSCM

Embryo culture in different single-step media:

Half of each patient's oocytes will be randomly allocated to be cultured in CSC medium for up to six days following oocyte retrieval.

Group Type ACTIVE_COMPARATOR

embryo culture in different single-step media

Intervention Type OTHER

Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.

Interventions

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embryo culture in different single-step media

Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* at least 10 oocytes retrieved

Exclusion Criteria

* frozen oocytes
* testicular biopsy
* less than 10 oocytes retrieved
* older than 40 years
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

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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Sfontouris IA, Kolibianakis EM, Lainas GT, Venetis CA, Petsas GK, Tarlatzis BC, Lainas TG. Blastocyst utilization rates after continuous culture in two commercial single-step media: a prospective randomized study with sibling oocytes. J Assist Reprod Genet. 2017 Oct;34(10):1377-1383. doi: 10.1007/s10815-017-0997-0. Epub 2017 Jul 17.

Reference Type DERIVED
PMID: 28718081 (View on PubMed)

Other Identifiers

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Sage vs CSCM

Identifier Type: -

Identifier Source: org_study_id

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