The Embryologist's Impact on Blastocyst Vitrification and Thawing

NCT06220227 | Completed

• 1 other identifier: EMBRYOFACTOR2
• Study Type: observational
• Target: 6,800
• Locations: 1 country
• Sites: 1

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

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

• clinical pregancy rate

  visualisation of the gestation sac in the uterus by ultrasound over the number of ET cycles performed

  January 2019-June 2023

Study Arms (2)

embryologist freezing the embryo

Procedure: vitrification and thawing procedures

embryologist thawing the embryo

Procedure: vitrification and thawing procedures

Interventions

vitrification and thawing procedures PROCEDURE

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 freezing the embryo; embryologist thawing the embryo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• IRCCS San Raffaele: collaborator

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Vitrification

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Phase Transition; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 23, 2024
• Study Start: January 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

IT (1)