Embryo Development Using Two Commercial Single-step Media
Embryo Development and Utilization Using Two Commercial Single-step Media
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 25, 2014
CompletedFirst Posted
Study publicly available on registry
November 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 9, 2015
June 1, 2015
7 months
November 25, 2014
June 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Utilization rates
Utilization = embryos selected for transfer and cryopreservation
6 days post oocyte retrieval
Blastocyst formation
Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes
5 days post oocyte retrieval
Secondary Outcomes (4)
Embryo quality on day 3
3 days post oocyte retrieval
blastocyst quality on day 5
5 days post oocyte retrieval
positive pregnancy test
15 days post oocyte retrieval
clinical pregnancy
7 weeks of gestation
Study Arms (2)
Sage 1-step
ACTIVE COMPARATOREmbryo 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.
CSCM
ACTIVE COMPARATOREmbryo 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- at least 10 oocytes retrieved
You may not qualify if:
- frozen oocytes
- testicular biopsy
- less than 10 oocytes retrieved
- older than 40 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eugonialead
Study Sites (1)
Eugonia Assisted Reproduction Unit
Athens, Attica, 11528, Greece
Related Publications (1)
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.
PMID: 28718081DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ioannis A Sfontouris, PhD
Eugonia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2014
First Posted
November 27, 2014
Study Start
November 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 9, 2015
Record last verified: 2015-06