The Embryologist's Impact on Blastocyst Vitrification and Thawing

Female Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06220227
• Other study ID #: EMBRYOFACTOR2
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6800
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregancy rate	visualisation of the gestation sac in the uterus by ultrasound over the number of ET cycles performed	January 2019-June 2023