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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Origio; Other: Global

• Registration Number: NCT02048527
• Lead Sponsor: Eugonia

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Origio	Origio	In vitro embryo culture in sequential media (Origio)
Global	Global	In vitro embryo culture in single-step medium (Global)

Primary Outcome Measures

Name	Time	Method
Implantation rate per embryo transferred	7 weeks	Number of fetal sacs with positive heart beat at 7 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy	7 weeks	Pregnancy reaching 7 weeks of gestation
Blastocyst formation rate	Day 5	Embryos reaching the blastocyst stage on Day 5 post oocyte retrieval
Ongoing pregnancy rates	12 weeks	Pregnancy reaching 12 weeks of gestation
Good quality blastocysts	Day 5	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	14 days	Pregnancy test as assessed by detection of hCG using blood test
Early pregnancy loss	12 weeks	Miscarriage per positive hCG test up to 12 weeks of gestation

Trial Locations

Locations (1)

Eugonia Assisted Reproduction Unit; 🇬🇷 Athens, Attica, Greece