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Enrolling by invitation NCT01219361

Evaluation of Donated Human Embryos Following in Vitro Fertilization

Observational Validation of Laboratory Techniques Validation of Laboratory Methods Assessment of Laboratory Staff Proficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Validation of Laboratory Techniques, Validation of Laboratory Methods, Assessment of Laboratory Staff Proficiency. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Donated Human Embryos for Study of Normal and Abnormal Differentiation and Development Following in Vitro Fertilization.

Overview

Couples who have created excess embryos while undergoing IVF procedures, and who do not wish to transfer those embryos or donate them to another couple may donate the extra embryos to research. The embryos are then used to develop improved laboratory techniques and conditions as well as testing the proficiency of laboratory staff.

Detailed description

Undergoing IVF treatment often results in the production of more embryos than can safely be transferred at one time. These extra embryos are often cryopreserved for future use. In the event that a couple decides that they do not want to proceed with using cryopreserved embryos, these embryos can be discarded, donated to another couple, or donated to research.

Embryos that are donated to research are used to identify a group of parameters that have significant predictive value for assisted reproductive technology outcomes. We hope to develop future laboratory techniques as we gain a better knowledge of gamete development, fertilization and implantation. We will test, standardize and implement better methods for freezing embryos prior to employing these techniques in a clinical setting. We hope to develop new methods to optimize the determination of genes and chromosomes in embryos. We will test the proficiency of laboratory staff on techniques and/or procedures done in the IVF laboratory. This study WILL NOT:create embryos for research, transfer embryos to an individual, develop cell lines or clones.

Primary outcome measures

  • Freezing methods for embryos [Time frame: duration of the study]
Secondary outcome measures (1)
  • Development of New Methods [Time frame: duration of the study]

Eligibility criteria

Inclusion criteria

none

Exclusion criteria

none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 1 center
  • Reproductive Medicine Assoicates of New Jersey — Basking Ridge

Identifiers

NCT: NCT01219361 · RMA-00-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗