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

NCT ID: NCT01427413

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2023-12-31

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the way for direct assessment of embryos through the mass spectrometry-based analysis of blastocoele fluid, which is withdrawn from the blastocoele cavity prior to cryostorage of blastocysts.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.

Conditions

Blastocoele Fluid

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Hyper1

Only patients who achieved hyperstimulation pathology after external administration of gonadotrophin during IVF treatment

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Ovarian hyperstimulation disease
• Blastocyst formation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi La Tuscia

UNKNOWN

Sponsor Role: collaborator

Tecnobios Riproduzione

UNKNOWN

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: collaborator

Cervesi Hospital, Cattolica, Italy

OTHER

Sponsor Role: lead

Responsible Party

Palini Simone

Embryologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Palini, biology

Role: STUDY_DIRECTOR

Cervesi Hospital, Cattolica, Italy

Locations

Cervesi Hospital

Cattolica, Rimini, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Simone Palini, biology

Role: CONTACT

simonepalini@yahoo.it

+39 339 4572101

Silvia De Stefani, Biotecnology

Role: CONTACT

silvia.destefani83@libero.it

+39 320 1111937

Facility Contacts

Silvia De Stefani, Biotecnology

Role: primary

silvia.destefani83@libero.it

+39 320 1111937

Simone Palini, biology

Role: backup

simonepalini@yahoo.it

+39 339 4572101

Other Identifiers

SS4e

Identifier Type: -

Identifier Source: org_study_id