The Embryologist's Impact on Blastocyst Vitrification and Thawing

Istituto Clinico Humanitas

Status

Completed

Conditions

Female Infertility

Treatments

Procedure: vitrification and thawing procedures

Study type

Observational

Funder types

Other

Identifiers

NCT06220227

EMBRYOFACTOR2

Details and patient eligibility

About

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

Enrollment

6,800 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

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.