Clinical trial NCT06220227: The Embryologist's Impact on Blastocyst Vitrification and Thawing
Official title: The Embryologist's Impact on Blastocyst Vitrification and Thawing: a Monocentric Retrospective Study With an External Validation Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Infertility
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
First posted: 2024-01-23
Enrollment: 6800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study sample will include all the embryologists who freeze and thawed the embryos used for ART cycles at Humanitas Fertility Center between January 2019 and June 2023, matching the inclusion and exclusion criteria cited above.

Brief summary: The goal of this monocentric retrospective observational study is to analyse, for the first time in literature, the role of the embryologist who freezes and thaws the embryos.

The primary objective of the study is to understand whether the embryologist who freezes and thaws the embryo influences the CPR (clinical pregnancy rate).

Secondary objectives, in case of statistically significant influence, are:

* Evaluate who influences more the CPR, between the embryologist who freezes the embryos and the embryologist who thaws the embryos.
* Evaluate if the embryologist who freezes and thaws the embryo impacts more than the embryologist or the physician who performs the ET.
* Evaluate whether the embryologists improve their performances, as their experience increases.
* Evaluate, through an external validation test, whether the model used can also be applied at other PMA centres

The study will consider all the freezing (vitrifications) and thawing procedures, performed at Humanitas Fertility Center between January 2019 and June 2023.

The study will include the transfers of single blastocysts, cryopreserved at Humanitas Fertility Center. On the other hand, the blastocysts transferred from other centres and the donor blastocysts will be excluded from the study, as well as multiple blastocysts transfers and the LP cycles.

The embryologist's experience will be assessed in terms of number of previous cryopreservation (vitrification) and thawing procedures. We will include in the study all the embryologists who performed at least 50 freezing and thawing.

For the evaluation of the study objectives, data will be gathered using a specific internal web-based database.

The final model will be created by analysing the Humanitas Fertility Center dataset and validated using datasets extrapolated from similar population from the San Raffaele Hospital infertility centre


Eligibility criteria: Inclusion Criteria:

The study database will include all the patients who performed a single cryopreserved blastocyst transfer, between January 2019 and June 2023, including also PGTA and repeated ART cycles.

The embryologist's experience will be assessed in terms of number of previous cryopreservation (vitrification) and thawing procedures. We will include in the study all the embryologists who performed at least 50 freezing and thawing.

Exclusion Criteria:

The blastocysts transferred from other centres and the donor blastocysts will be excluded from the study, as well as multiple blastocysts transfers and the LP cycles, to reduce the risk of selection bias or physician-embryologist couple bias.

The embryologists who performed less than 50 freezing and thawing will be excluded from the study.

Similarly, the first 50 procedures performed by each embryologist will not be counted in the data set.

Primary outcomes:
measure: clinical pregancy rate
timeFrame: January 2019-June 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
References: