Clinical trial NCT02048527: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Implantation rate per embryo transferred
timeFrame: 7 weeks
Secondary outcomes:
measure: Blastocyst formation rate
timeFrame: Day 5
measure: Good quality blastocysts
timeFrame: Day 5
measure: Positive hCG rates
timeFrame: 14 days
measure: Ongoing pregnancy rates
timeFrame: 12 weeks
measure: Early pregnancy loss
timeFrame: 12 weeks
measure: Clinical pregnancy
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia Assisted Reproduction Unit
state: Attica
Study officials:
affiliation: Eugonia
name: Ioannis A Sfontouris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eugonia
name: Trifon G Lainas, PhD
role: STUDY_DIRECTOR
References:
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.
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.