The Embryologist's Impact on Blastocyst Vitrification and Thawing

The Embryologist's Impact on Blastocyst Vitrification and Thawing: a Monocentric Retrospective Study With an External Validation Study.

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

Study Overview

• Status: Completed
• Conditions: Female Infertility
• Intervention / Treatment: Procedure: vitrification and thawing procedures

• Study Type: Observational
• Enrollment (Actual): 6800

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
embryologist freezing the embryo	Procedure: vitrification and thawing procedures; Vitrification and thawing are crucial steps in infertility treatment. Vitrification solutions are aqueous cryoprotectant solutions that undergo solidification (and not freezing) when cooled at high rates to very low temperatures, thanks to an increase in viscosity. Thawing consists in remove the cryoprotectants, warm and dilute the blastocyst.
embryologist thawing the embryo	Procedure: vitrification and thawing procedures; Vitrification and thawing are crucial steps in infertility treatment. Vitrification solutions are aqueous cryoprotectant solutions that undergo solidification (and not freezing) when cooled at high rates to very low temperatures, thanks to an increase in viscosity. Thawing consists in remove the cryoprotectants, warm and dilute the blastocyst.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregancy rate	visualisation of the gestation sac in the uterus by ultrasound over the number of ET cycles performed	January 2019-June 2023

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Estimated): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: EMBRYOFACTOR2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No