Ovary; AnomalyNCT03649087
Vitrification for Ovarian Tissue Harvesting
A study testing Vitrification in people with Ovary; Anomaly, run by Maximilian Franz, M.D. at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovary; Anomaly
- What is being tested?
- Vitrification
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female-to-male transsexuals
- gender completing operation
- signed informed consent form
- willingness to donate ovarian tissue for research purposes
- age >=18 years
Who cannot join
- malignant disease
- age under 18 years
- refusal to donate ovarian tissue
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University Clinic of Obstetrics and Gynaecology of the Medical University of Vienna
Vienna, 1090
Julian Marschalek, MD, 0043140400 ext. 28970, julian.marschalek@meduniwien.ac.at
Detlef Pietrowski, Dr., 0043140400 ext. 28970, detlef.pietrowski@meduniwien.ac.at
About this study
Official title: Testing of Vitrification Protocols for Ovarian Tissue Harvesting in Female to Male Transsexuals
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.
- Conditions
- Ovary; Anomaly
- Being tested
- Vitrification
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrificationOther
Vitrification of ovarian tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
survival of ovarian tissue
histologic and enzymatic evaluation of ovarian tissue with respect to survival and functionality of ovarian follicles
Measured: 2 days until 2 years after freezing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Oct 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovary; AnomalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Vitrification of ovarian tissue
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maximilian Franz, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maximilian Franz, M.D., Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649087
- Sponsor's protocol ID
- 2204
- Status last verified
- Aug 2018
- First submitted
- 29 Oct 2017
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34872604Marschalek 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.
PubMed 32891132
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Vitrification Protocols for Ovarian Tissue Harvesting in Female to Male Transsexuals
- ClinicalTrials.gov ID
- NCT03649087
- Acronym / sponsor ID
- 2204
- Conditions
- Ovary; Anomaly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maximilian Franz, M.D.University, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Vitrification of ovarian tissue
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female-to-male transsexuals
- gender completing operation
- signed informed consent form
- willingness to donate ovarian tissue for research purposes
- age >=18 years
Key exclusion criteria (3 listed)
- malignant disease
- age under 18 years
- refusal to donate ovarian tissue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitrificationVitrification of ovarian tissue | Other | – |
Primary outcome
survival of ovarian tissue
Time frame: 2 days until 2 years after freezing
histologic and enzymatic evaluation of ovarian tissue with respect to survival and functionality of ovarian follicles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Derived from this study: PubMed 34872604Marschalek 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.
- Derived from this study: PubMed 32891132Marschalek 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrification in people with Ovary; Anomaly, run by Maximilian Franz, M.D. at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian Marschalek, MD (0043140400 ext. 28970, julian.marschalek@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival of ovarian tissue (time frame: 2 days until 2 years after freezing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03649087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.