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Embryo Development Using Two Commercial Single-step Media

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
embryo culture in different single-step media
Sponsored by
Eugonia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring single-step media, embryo development, blastocyst formation, embryo utilization

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • at least 10 oocytes retrieved

Exclusion Criteria:

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

Sites / Locations

  • Eugonia Assisted Reproduction Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sage 1-step

CSCM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Utilization rates
Utilization = embryos selected for transfer and cryopreservation
Blastocyst formation
Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes

Secondary Outcome Measures

Embryo quality on day 3
blastocyst quality on day 5
positive pregnancy test
clinical pregnancy
presence of gestational sac with positive fetal heartbeat

Full Information

First Posted
November 25, 2014
Last Updated
June 8, 2015
Sponsor
Eugonia
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1. Study Identification

Unique Protocol Identification Number
NCT02302638
Brief Title
Embryo Development Using Two Commercial Single-step Media
Official Title
Embryo Development and Utilization Using Two Commercial Single-step Media
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eugonia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
single-step media, embryo development, blastocyst formation, embryo utilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sage 1-step
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CSCM
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
embryo culture in different single-step media
Intervention Description
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.
Primary Outcome Measure Information:
Title
Utilization rates
Description
Utilization = embryos selected for transfer and cryopreservation
Time Frame
6 days post oocyte retrieval
Title
Blastocyst formation
Description
Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes
Time Frame
5 days post oocyte retrieval
Secondary Outcome Measure Information:
Title
Embryo quality on day 3
Time Frame
3 days post oocyte retrieval
Title
blastocyst quality on day 5
Time Frame
5 days post oocyte retrieval
Title
positive pregnancy test
Time Frame
15 days post oocyte retrieval
Title
clinical pregnancy
Description
presence of gestational sac with positive fetal heartbeat
Time Frame
7 weeks of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: at least 10 oocytes retrieved Exclusion Criteria: frozen oocytes testicular biopsy less than 10 oocytes retrieved older than 40 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis A Sfontouris, PhD
Organizational Affiliation
Eugonia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eugonia Assisted Reproduction Unit
City
Athens
State/Province
Attica
ZIP/Postal Code
11528
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
28718081
Citation
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.
Results Reference
derived

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Embryo Development Using Two Commercial Single-step Media

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