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NCT06220227
The Embryologist's Impact on Blastocyst Vitrification and Thawing
trial testing vitrification and thawing procedures in Female Infertility in 6,800 participants. Completed in 30 June 2023.
30 June 2023
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 6,800 |
| Start date | 1 January 2019 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- vitrification and thawing procedures
Conditions studied
- Female Infertility — all drugs for Female Infertility →
Sponsor
Istituto Clinico Humanitas
Who can join
Eligibility, any sex, with Female Infertility. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06220227
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06220227 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
- Last refreshed: 23 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06220227.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing