Reproductive Performance Following Ovarian TransplantationPhase 3NCT02659592
Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance
A Phase 3 study testing transplantation of ovarian tissue in people with Reproductive Performance Following Ovarian Transplantation, run by Sheba Medical Center.
Trial summary
Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed ovarian tissue, with the aim to conceive. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Reproductive Performance Following Ovarian Transplantation
- What is being tested?
- transplantation of ovarian tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2015
- Phase
- Phase 3
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- active disease, fertile patients post cancer treatment
About this study
Official title: Transplantation of Frozen Thawed Ovarian Tissue Demonstrates High Reproductive Performance and the Need to Revise Restrictive Criteria
Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed ovarian tissue, with the aim to conceive.
Interventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine monitoring, IVF.
Read the detailed description
Main Outcomes expected:
Endocrine profile IVF results, pregnancy rates following transplantation of ovarian tissue live-births rates following transplantation of ovarian tissue cancer disease recurrence
- Being tested
- transplantation of ovarian tissue
- Keywords
- fertility preservation, ovarian tissue transplantation, ovarian endocrine function, assisted reproductive technology, pregnancy and live birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplantation of ovarian tissueProcedure or surgery
operation(mini laparotomy) for transplantation of frozen- thawed ovarian tissue
| Study group | Role | What they receive |
|---|---|---|
| infertile cancer survivors | Experimental | infertile cancer survivors who seek to conceive and had frozen ovarian tissue when diagnosed years before Receives: Procedure: transplantation of ovarian tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
menstrual bleeding (yes/no)
recurrence of menstrual bleeding- yes or no
Measured: up to one year
number of oocytes per IVF cycle
number of aspirated oovytes per one IVF cycle performed
Measured: through study completion (up to 11 years following transplantation)
pregnancies
spontaneous or post IVF pregnancy rates (%)
Measured: through study completion (up to 11 years following transplantation)
live births
live birth rates (%)
Measured: through study completion (up to 11 years following transplantation)
Secondary outcomes (1)
disease reccurence
incidence of cancer disease recurrence
Measured: through study completion (7 months to 141 months following transplantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2004
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reproductive Performance Following Ovarian TransplantationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Dror Meirow, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659592
- Sponsor's protocol ID
- SHEBA-03-3026-DM-CTIL
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Meirow D, Ra'anani H, Shapira M, Brenghausen M, Derech Chaim S, Aviel-Ronen S, Amariglio N, Schiff E, Orvieto R, Dor J. Transplantations of frozen-thawed ovarian tissue demonstrate high reproductive performance and the need to revise restrictive criteria. Fertil Steril. 2016 Aug;106(2):467-74. doi: 10.1016/j.fertnstert.2016.04.031. Epub 2016 May 12.
PubMed 27181924
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Frozen Thawed Ovarian Tissue Demonstrates High Reproductive Performance and the Need to Revise Restrictive Criteria
- ClinicalTrials.gov ID
- NCT02659592
- Acronym / sponsor ID
- SHEBA-03-3026-DM-CTIL
- Keywords
- fertility preservation, ovarian tissue transplantation, ovarian endocrine function, assisted reproductive technology, pregnancy and live birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2004
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jan 2016 (estimated)
- 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.
Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed ovarian tissue, with the aim to conceive.
Interventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine monitoring, IVF.
Detailed description
Main Outcomes expected:
Endocrine profile IVF results, pregnancy rates following transplantation of ovarian tissue live-births rates following transplantation of ovarian tissue cancer disease recurrence
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infertile cancer survivors | Experimental | Procedure: transplantation of ovarian tissueinfertile cancer survivors who seek to conceive and had frozen ovarian tissue when diagnosed years before |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- active disease, fertile patients post cancer treatment
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 |
|---|---|---|
| transplantation of ovarian tissueoperation(mini laparotomy) for transplantation of frozen- thawed ovarian tissue | Procedure or surgery | infertile cancer survivors |
Primary outcome
menstrual bleeding (yes/no)
Time frame: up to one year
recurrence of menstrual bleeding- yes or no
number of oocytes per IVF cycle
Time frame: through study completion (up to 11 years following transplantation)
number of aspirated oovytes per one IVF cycle performed
pregnancies
Time frame: through study completion (up to 11 years following transplantation)
spontaneous or post IVF pregnancy rates (%)
live births
Time frame: through study completion (up to 11 years following transplantation)
live birth rates (%)
1 secondary outcome
disease reccurence
Time frame: through study completion (7 months to 141 months following transplantation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Derived from this study: PubMed 27181924Meirow D, Ra'anani H, Shapira M, Brenghausen M, Derech Chaim S, Aviel-Ronen S, Amariglio N, Schiff E, Orvieto R, Dor J. Transplantations of frozen-thawed ovarian tissue demonstrate high reproductive performance and the need to revise restrictive criteria. Fertil Steril. 2016 Aug;106(2):467-74. doi: 10.1016/j.fertnstert.2016.04.031. Epub 2016 May 12.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transplantation of ovarian tissue in people with Reproductive Performance Following Ovarian Transplantation, run by Sheba Medical Center.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
menstrual bleeding (yes/no) (time frame: up to one year). The study lists 4 primary outcomes in all. 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 NCT02659592, which also lists 1 linked publication.
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 20 Jan 2016.