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| Name | Class |
|---|---|
| IRCCS San Raffaele | OTHER |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| embryologist freezing the embryo |
| ||
| embryologist thawing the embryo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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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.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D058989 | Vitrification |
| ID | Term |
|---|---|
| D044367 | Phase Transition |
| D055585 | Physical Phenomena |
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|
| D000091662 | Genital Diseases |
| D007246 | Infertility |