Comparison of Single-step (Global) Versus Sequential Media (Origio) in Preimplantation Embryo Development and Pregnancy Rates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 131
- Locations
- 2
- Primary Endpoint
- Implantation rate per embryo transferred
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Implantation rate per embryo transferred
Time Frame: 7 weeks
Number of fetal sacs with positive heart beat at 7 weeks of gestation
Secondary Outcomes
- Clinical pregnancy(7 weeks)
- Blastocyst formation rate(Day 5)
- Ongoing pregnancy rates(12 weeks)
- Good quality blastocysts(Day 5)
- Positive hCG rates(14 days)
- Early pregnancy loss(12 weeks)