Status:
COMPLETED
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
Lead Sponsor:
University of Luebeck
Conditions:
Infertility
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The GAVI® closed vitrification system is a CE labelled device licensed for use in human IVF. It has been developed to standardize the process of vitrification and to increase the safety of the procedu...
Detailed Description
One hundred and eighty (n=180) patients presenting more than 2 surplus 2 PNoocytes for vitrification or patients having all available 2PN oocytes electively vitrified will be randomly allocated (1:1) ...
Eligibility Criteria
Inclusion
- IVF or ICSI treatment
- 2 or more surplus 2 PN oocytes OR elective cryopreservation of all 2 PN oocytes on day of fertilization check
- willingness to participate (signed ICF)
Exclusion
- history of low response to controlled ovarian hyper stimulation in previous IVF or ICSI treatments (ESHRE Bologna criteria; Ferranetti et al., Hum Reprod 2011)
- uterine pathology evident on transvaginal sonography, hysterosalpingography, hysteroscopy or laparoscopy
- participation in a PGS or PGD program
- previous participation in this study
Key Trial Info
Start Date :
September 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2020
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT03287479
Start Date
September 6 2018
End Date
November 25 2020
Last Update
November 30 2020
Active Locations (3)
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1
Universitäres Kinderwunschzentrum Kiel
Kiel, Germany, 24105
2
Universitäres Kinderwunschzentrum Lübeck
Lübeck, Germany, 23562
3
Kinderwunsch-Zentrum Ulm
Ulm, Germany, 89077