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

Infertility Clinical Trial

Official title:

Comparison of Single-step (Global) Versus Sequential Media (Origio) in Preimplantation Embryo Development and Pregnancy Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048527
• Other study ID #: Global versus Origio
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: December 15, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Eugonia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Global
Single medium for the culture of embryos from Day1 to Day 5
• Origio
Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)

Locations

Country	Name	City	State
Greece	Eugonia Assisted Reproduction Unit	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Basile N, Morbeck D, García-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. — View Citation

Sepúlveda 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate per embryo transferred	Number of fetal sacs with positive heart beat at 7 weeks of gestation	7 weeks	No
Secondary	Blastocyst formation rate	Embryos reaching the blastocyst stage on Day 5 post oocyte retrieval	Day 5	No
Secondary	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.	Day 5	No
Secondary	Positive hCG rates	Pregnancy test as assessed by detection of hCG using blood test	14 days	No
Secondary	Ongoing pregnancy rates	Pregnancy reaching 12 weeks of gestation	12 weeks	No
Secondary	Early pregnancy loss	Miscarriage per positive hCG test up to 12 weeks of gestation	12 weeks	No
Secondary	Clinical pregnancy	Pregnancy reaching 7 weeks of gestation	7 weeks	No