InfertilityNCT01682525
Ovarian Tissue Cryopreservation for Fertility Preservation
A study testing Frozen ovarian tissue in people with Infertility, run by Boston IVF at 2 sites in United States.
Trial summary
To provide a novel fertility preservation option for patients facing a fertility threatening cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation program. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Frozen ovarian tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Mar 2015
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy which are likely to result in permanent loss of subsequent ovarian function or diminished fertility
- Have a medical condition or malignancy that requires removal of all or part of one or both ovaries
- Patients may have newly diagnosed or recurrent disease
- Be in good health so as to be able to undergo laparoscopic surgery as determined by history and physical examinations, and consultation with the medical oncologist, reproductive endocrinologist, surgeon and anesthesiologist
Who cannot join
- Moderate to high-risk of ovarian failure due to treatment
- Documented ovarian metastasis
- HIV or hepatitis (B, C)-positive serology
- Absolute surgical contraindications
- ECOG performance status of 0 or 1
- Pregnancy
- Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Newton Wellesley Hospital
Newton, Massachusetts, 02462
Boston IVF
Waltham, Massachusetts, 02451
About this study
To provide a novel fertility preservation option for patients facing a fertility threatening cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation program. To determine if ovarian tissue cryopreservation provides women with a useful, successful option for fertility preservation
The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an alternative option for fertility preservation.
- Conditions
- Infertility
- Being tested
- Frozen ovarian tissue
- Keywords
- Fertility preservation, Ovarian Tissue, Cryopreservation, Assisted Reproductive Technology
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frozen ovarian tissueOther
Use of ovarian tissue cryopreserved and stored at Boston IVF
| Study group | Role | What they receive |
|---|---|---|
| Ovarian tissue cryopreservation | Experimental | The ovarian tissue is cryopreserved and stored at Boston IVF, which is an FDA compliant and American Association of Tissue Banks accredited long term storage facility for reproductive tissue. Receives: Other: Frozen ovarian tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety, which will be assessed by tracking the number of minor and major complications of the procedure including the following:
- Minor: Local infection
- Major: Blood loss requiring blood transfusion, major infection requiring admission or parental antibiotics, injury to surrounding organs requiring further procedures, hospitalization due to unforeseen operative complication
Measured: 10 years
Secondary outcomes (1)
Efficacy
- Proportion of women who attempt pregnancy
- Proportion of women who become pregnant and outcome
- Proportion of women using assisted reproduction after re-implantation or ovarian tissue.
- Menstrual cyclicity and ovarian reserve in those with and without re-implantation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston IVF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ryley, MD, Boston IVF
- Investigators
- David Ryley, MD, Principal investigator, Boston IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682525
- Sponsor's protocol ID
- N09-454
- Status last verified
- Feb 2016
- First submitted
- 4 Sep 2012
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Tissue Cryopreservation for Fertility Preservation
- ClinicalTrials.gov ID
- NCT01682525
- Acronym / sponsor ID
- N09-454
- Conditions
- Infertility
- Keywords
- Fertility preservation, Ovarian Tissue, Cryopreservation, Assisted Reproductive Technology
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Sep 2012 (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.
To provide a novel fertility preservation option for patients facing a fertility threatening cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation program. To determine if ovarian tissue cryopreservation provides women with a useful, successful option for fertility preservation
The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an alternative option for fertility preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian tissue cryopreservation | Experimental | Other: Frozen ovarian tissueThe ovarian tissue is cryopreserved and stored at Boston IVF, which is an FDA compliant and American Association of Tissue Banks accredited long term storage facility for reproductive tissue. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy which are likely to result in permanent loss of subsequent ovarian function or diminished fertility
- Have a medical condition or malignancy that requires removal of all or part of one or both ovaries
- Patients may have newly diagnosed or recurrent disease
- Be in good health so as to be able to undergo laparoscopic surgery as determined by history and physical examinations, and consultation with the medical oncologist, reproductive endocrinologist, surgeon and anesthesiologist
Key exclusion criteria (7 listed)
- Moderate to high-risk of ovarian failure due to treatment
- Documented ovarian metastasis
- HIV or hepatitis (B, C)-positive serology
- Absolute surgical contraindications
- ECOG performance status of 0 or 1
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 |
|---|---|---|
| Frozen ovarian tissueUse of ovarian tissue cryopreserved and stored at Boston IVF | Other | Ovarian tissue cryopreservation |
Primary outcome
Safety
Time frame: 10 years
Safety, which will be assessed by tracking the number of minor and major complications of the procedure including the following: * Minor: Local infection * Major: Blood loss requiring blood transfusion, major infection requiring admission or parental antibiotics, injury to surrounding organs requiring further procedures, hospitalization due to unforeseen operative complication
1 secondary outcome
Efficacy
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
David Ryley, MD principal investigator
Boston IVF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frozen ovarian tissue in people with Infertility, run by Boston IVF at 2 sites in United States.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2016.