Clinical trial NCT01427413: Identification and Standardization of a Method That Would Allow the Study of the Metabolic Profile of Blastocoele Lays the Foundation to Assess Blastocyst Metabolomic Profile and Its Relation With Embryo Morphology and Embryo Implantation
Official title: Identification and Standardization of a Method That Would Allow the Study of the Metabolic Profile of Blastocoele Lays the Foundation to Assess Blastocyst Metabolomic Profile and Its Relation With Embryo Morphology and Embryo Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blastocoele Fluid
Keywords: blastocoele fluid
mass spectrometry
metabolomics
Lead sponsor: Cervesi Hospital, Cattolica, Italy
Sponsor class: OTHER
Collaborators: name: Università degli Studi La Tuscia
name: Tecnobios Riproduzione
name: Istituto Clinico Humanitas
First posted: 2011-09-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients that are unable to be subjected to embryo transfer due to her ovarian hyperstimulation. In those cases the embryos will be vitrified and during this procedure we collapse the blastocyst sucking the fluid.

Brief summary: While the number of assisted reproduction cycles increases worldwide, the introduction of actual technological improvements in the ability to quickly and non-invasively identify the best embryos for transfer still represents a critical goal for reproductive medicine. Indeed, embryo assessment is currently performed through the analysis of morphology and cleavage rate. Recent studies have sought to identify a correlation between qualitative-quantitative profiles of small molecules of metabolic interest and the outcome of embryo transfer. Some of these molecules seem to be best suited for this purpose, including glucose, lactate, pyruvate or amino acid levels. Approaches relying on both optical and non-optical spectroscopy have been proposed to non-invasively monitor the embryo culture media. However, the non-invasive approach only offers an indirect strategy to monitor embryos and a turn-around solution to bypass the limits of detection of these analytical techniques. In this paper the investigators pave the way for direct assessment of embryos through the mass spectrometry-based analysis of blastocoele fluid, which is withdrawn from the blastocoele cavity prior to cryostorage of blastocysts. The investigators show how it is possible to detect most of the already documented metabolites of interest right at the very heart of the blastocyst, without disrupting the workflow of a classic laboratory pipeline.


Eligibility criteria: Inclusion Criteria:

* Ovarian hyperstimulation disease
* Blastocyst formation

Primary outcomes:
measure: standardize the method of aspiration
timeFrame: 2 months
measure: metabolite detection
timeFrame: 6 months
Secondary outcomes:
measure: analysis of the correlation between blastocyst morphology and metabolic profile in the blastocoele fluid
timeFrame: 1 year
Other outcomes:
Locations:
city: Cattolica
country: Italy
facility: Cervesi Hospital
state: Rimini
Study officials:
affiliation: Cervesi Hospital, Cattolica, Italy
name: Simone Palini, biology
role: STUDY_DIRECTOR
References: