Clinical trial

Cumulus Cell Mitochondrial Activity as a Non-invasive Marker of Embryo Quality

Name
11/21/DD/BVMD
Description
This study aims to test the extent of association of FLIM parameters of cumulus cells with clinical outcomes (clinical pregnancy, ongoing pregnancy at 12 weeks, and live birth) of the embryos that result from the enclosed oocytes.
Trial arms
Trial start
2022-04-25
Estimated PCD
2024-06-30
Trial end
2025-03-30
Status
Recruiting
Treatment
FLIM parameters
Cumulus samples (CCs) will be collected following the protocol on the day of oocyte pick up (OPU). CCs are frozen by the cryo-tech method, then stored in liquid nitrogen at -196oC. Information of CC samples and processed date/time is recorded. After all, samples are collected, they will be transferred to The Needleman Lab, Northwest Lab Building 359,52 Oxford Street Cambridge MA 02138 to measure mitochondria metabolism using FLIM.
Arms:
Infertile women have IVF/ICSI cycle
Other names:
fluorescence lifetime imaging microscopy
Size
200
Primary endpoint
Live birth rate after one frozen embryo transfer cycle
After 24 week's gestation
Eligibility criteria
Inclusion Criteria: * Having any number of IVF/ICSI attempts * Ovarian stimulation with any stimulation protocol * Patients with at least 8 follicles ≥ 10 mm on ultrasonography at induced ovulation date * Agreed to freeze-all day 5-6 embryos * Agreed to have a single day 5-6 embryo transfer. * Agreed to participate in the research (signed the consent form) Exclusion Criteria: * In vitro maturation (IVM) cycles * Cycles using testicular biopsy or epididymal sperm * Cycles not having an oocyte freeze-all cycle * Cycles using standard insemination * Participating in another research
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cumulus cell of oocyte'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

1 product

4 indications

Product
FLIM
Indication
IVF/ICSI
Indication
Cumulus Cell