Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Global
Origio
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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
Sites / Locations
- Eugonia Assisted Reproduction Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Global
Origio
Arm Description
In vitro embryo culture in single-step medium (Global)
In vitro embryo culture in sequential media (Origio)
Outcomes
Primary Outcome Measures
Implantation rate per embryo transferred
Number of fetal sacs with positive heart beat at 7 weeks of gestation
Secondary Outcome Measures
Blastocyst formation rate
Embryos reaching the blastocyst stage on Day 5 post oocyte retrieval
Good quality blastocysts
Good quality blastocysts are considered at least full blastocysts (stage 3 and above) with grade A or grade B inner-cell mass and trophectoderm respectively.
Positive hCG rates
Pregnancy test as assessed by detection of hCG using blood test
Ongoing pregnancy rates
Pregnancy reaching 12 weeks of gestation
Early pregnancy loss
Miscarriage per positive hCG test up to 12 weeks of gestation
Clinical pregnancy
Pregnancy reaching 7 weeks of gestation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02048527
Brief Title
Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates
Official Title
Comparison of Single-step (Global) Versus Sequential Media (Origio) in Preimplantation Embryo Development and Pregnancy Rates
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (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
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Global
Arm Type
Active Comparator
Arm Description
In vitro embryo culture in single-step medium (Global)
Arm Title
Origio
Arm Type
Active Comparator
Arm Description
In vitro embryo culture in sequential media (Origio)
Intervention Type
Other
Intervention Name(s)
Global
Other Intervention Name(s)
Global medium (LIfeGlobal)
Intervention Description
Single medium for the culture of embryos from Day1 to Day 5
Intervention Type
Other
Intervention Name(s)
Origio
Other Intervention Name(s)
ISM1/BlastAssist (Origio)
Intervention Description
Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)
Primary Outcome Measure Information:
Title
Implantation rate per embryo transferred
Description
Number of fetal sacs with positive heart beat at 7 weeks of gestation
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Blastocyst formation rate
Description
Embryos reaching the blastocyst stage on Day 5 post oocyte retrieval
Time Frame
Day 5
Title
Good quality blastocysts
Description
Good quality blastocysts are considered at least full blastocysts (stage 3 and above) with grade A or grade B inner-cell mass and trophectoderm respectively.
Time Frame
Day 5
Title
Positive hCG rates
Description
Pregnancy test as assessed by detection of hCG using blood test
Time Frame
14 days
Title
Ongoing pregnancy rates
Description
Pregnancy reaching 12 weeks of gestation
Time Frame
12 weeks
Title
Early pregnancy loss
Description
Miscarriage per positive hCG test up to 12 weeks of gestation
Time Frame
12 weeks
Title
Clinical pregnancy
Description
Pregnancy reaching 7 weeks of gestation
Time Frame
7 weeks
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:
<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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis A Sfontouris, PhD
Organizational Affiliation
Eugonia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trifon G Lainas, PhD
Organizational Affiliation
Eugonia
Official's Role
Study Director
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
18439587
Citation
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.
Results Reference
background
PubMed Identifier
23315059
Citation
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.
Results Reference
background
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Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates
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