NCT03287479

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 procedure. It has been demonstrated that the novel semiautomated, closed vitrification system providing standardized equilibration prior to cryopreservation can produce similar results in terms of recovery rate and Embryo development up to the blastocyst stage as compared to the commonly used Manual Cryotop® open vitrifcation system when applied in a mouse model. Furthermore, its application has resulted in first pregnancies after transfer of vitrifiedwarmed biopsied human blastocyts. Due to limitations of the preliminary studies (application in mouse model; absence of a larger clinical Trial assessing pregnancy and live birth rates in human model etc.) it is of paramount importance to compare the GAVI® vitrification method to the routinely used Cryotop® method in a human IVF setting employing randomization and a-priori sample size definitions. The primary objective of this study is to demonstrate non-inferiority of vitrification using the semi-automated GAVI® closed system over the so-far routinely used manual Cryotop® open system in terms of post-thawing survival rate of 2PN oocytes. The secondary objective of this trial is to study differences in embryo development, clinical pregnancy rate, ongoing pregnancy rate and live birth rate. Furthermore, differences in procedure duration and convenience will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

September 6, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

September 1, 2017

Last Update Submit

November 25, 2020

Conditions

Infertility

Keywords

vitrificationsemi-automatedmanual

Outcome Measures

Primary Outcomes (1)

  • post-thawing survival rate

    confirmation of survival by presence of intact oolemma and regular cytoplasm 2 hours post warming procedure and by observation of embryonic cleavage on

    2 hours

Secondary Outcomes (7)

  • Number of top quality embryos on day 2

    2 days

  • Number of top quality embryos on day 3

    3 days

  • Number of top quality embryos on day 5

    5 days

  • Number of top quality embryos on day 6

    6 days

  • Clinical pregnancy rate

    6 weeks

  • +2 more secondary outcomes

Other Outcomes (2)

  • Procedure duration

    1 day

  • Convenience

    1 day

Study Arms (2)

Gavi®

EXPERIMENTAL

surplus or all fertilized oocytes will be cryoperserved by utilizing the closed, semi-automated Gavi® vitrification system

Procedure: Gavi® Vitrification

Cryotop®

ACTIVE COMPARATOR

surplus or all fertilized oocytes will be cryoperserved by utilizing the open, manual Cryotop® vitrification system

Procedure: Cryotop® Vitrification

Interventions

Gavi® VitrificationPROCEDURE

A closed, semi-automated vitrification system

Gavi®
Cryotop® VitrificationPROCEDURE

An open, manual vitrification system

Cryotop®

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • IVF or ICSI treatment
  • or more surplus 2 PN oocytes OR elective cryopreservation of all 2 PN oocytes on day of fertilization check
  • willingness to participate (signed ICF)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitäres Kinderwunschzentrum Kiel

Kiel, 24105, Germany

Location

Universitäres Kinderwunschzentrum Lübeck

Lübeck, 23562, Germany

Location

Kinderwunsch-Zentrum Ulm

Ulm, 89077, Germany

Location

Related Publications (2)

  • Roy TK, Brandi S, Tappe NM, Bradley CK, Vom E, Henderson C, Lewis C, Battista K, Hobbs B, Hobbs S, Syer J, Lanyon SR, Dopheide SM, Peura TT, McArthur SJ, Bowman MC, Stojanov T. Embryo vitrification using a novel semi-automated closed system yields in vitro outcomes equivalent to the manual Cryotop method. Hum Reprod. 2014 Nov;29(11):2431-8. doi: 10.1093/humrep/deu214. Epub 2014 Aug 27.

    PMID: 25164022BACKGROUND

  • Hajek J, Baron R, Sandi-Monroy N, Schansker S, Schoepper B, Depenbusch M, Schultze-Mosgau A, Neumann K, Gagsteiger F, von Otte S, Griesinger G. A randomised, multi-center, open trial comparing a semi-automated closed vitrification system with a manual open system in women undergoing IVF. Hum Reprod. 2021 Jul 19;36(8):2101-2110. doi: 10.1093/humrep/deab140.

    PMID: 34131726DERIVED

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Georg Griesinger, Prof Dr MSc

    University of Luebeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Patients presenting ≥ 2 surplus regularly fertilized oocytes for cryoperservation on day 1 and patients undergoing elective cryopreservation of all available 2PN oocytes are are allocated to one of the two following procedures: Study group: surplus or all 2PN-stage oocytes are vitrified/warmed using the semiautomated Gavi® protocol. Control group: surplus or all 2PN-stage oocytes are vitrified/warmed using the manual Cryotop® protocol. Randomization will be performed on day of fertilization check by lab staff by opening a numbered, opaque sealed envelopes. The random sequence will be software-generated and blocks will be used.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. M.Sc.

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 19, 2017

Study Start

September 6, 2018

Primary Completion

November 25, 2020

Study Completion

November 25, 2020

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Fully anonymized data can be shared after primary publication upon reasonable request.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
from 12/2021 on
Access Criteria
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0532-z

Locations

DE(3)