NCT03649087

Brief Summary

Increasing interest has emerged concerning ovarian tissue cryopreservation and subsequent transplantation as a potential way of preserving fertility in cancer patients as well as for women who just wish to delay childbearing. As the majority of existing protocols use the slow freezing method, this study aims to test vitrification techniques of ovarian cortex.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

October 29, 2017

Last Update Submit

August 25, 2018

Conditions

Ovary; Anomaly

Outcome Measures

Primary Outcomes (1)

  • survival of ovarian tissue

    histologic and enzymatic evaluation of ovarian tissue with respect to survival and functionality of ovarian follicles

    2 days until 2 years after freezing

Interventions

VitrificationOTHER

Vitrification of ovarian tissue

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale-to-male transsexuals
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female-to-male transsexuals
  • gender completing operation
  • signed informed consent form
  • willingness to donate ovarian tissue for research purposes
  • age \>=18 years

You may not qualify if:

  • malignant disease
  • age under 18 years
  • refusal to donate ovarian tissue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Obstetrics and Gynaecology of the Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (2)

  • Marschalek J, Egarter C, Nouri K, Dekan S, Ott J, Frank M, Pietrowski D. The effect of different vitrification protocols on cell survival in human ovarian tissue: a pilot study. J Ovarian Res. 2021 Dec 6;14(1):170. doi: 10.1186/s13048-021-00924-8.

    PMID: 34872604DERIVED

  • Marschalek J, Pietrowski D, Dekan S, Marschalek ML, Brandstetter M, Ott J. Markers of vitality in ovaries of transmen after long-term androgen treatment: a prospective cohort study. Mol Med. 2020 Sep 5;26(1):83. doi: 10.1186/s10020-020-00214-x.

    PMID: 32891132DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Vitrification

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phase TransitionPhysical Phenomena

Central Study Contacts

Julian Marschalek, MD

CONTACT

0043140400julian.marschalek@meduniwien.ac.at

Detlef Pietrowski, Dr.

CONTACT

0043140400detlef.pietrowski@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Vitrification of ovarian tissue
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 29, 2017

First Posted

August 28, 2018

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

AU(1)