Women Diagnosed With CancerPhase 2/3NCT01223105
Oocyte Cryopreservation by Slow Freezing and Vitrification
A Phase 2/3 study testing slow freeze and Vitrification in people with Women Diagnosed With Cancer and Egg Donors, run by Reproductive Medicine Associates of New Jersey.
Trial summary
This study seeks to evaluate whether the vitrification technique, as compared to the more traditional slow-cooling technique, leads to higher rates of successful thawing, fertilization, implantation and delivery. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Diagnosed With Cancer, Egg Donors, Single Women
- What is being tested?
- slow freeze and Vitrification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jul 2010
- Phase
- Phase 2/3
- 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 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 21 and 50 years, at the time of informed consent.
- Subjects must agree to undergo intracytoplasmic sperm injection (ICSI)
Who cannot join
- Presence of any medical condition that contraindicates ovarian stimulation, in vitro fertilization or pregnancy.
About this study
Official title: Longitudinal Evaluation of Vitrification of Human Oocytes
This study seeks to evaluate whether the vitrification technique, as compared to the more traditional slow-cooling technique, leads to higher rates of successful thawing, fertilization, implantation and delivery.
Read the detailed description
Cryopreservation (freezing) of human gametes (unfertilized egg) provides a great potential to preserve or extend fertility in the face of disease and social circumstances (cancer diagnosis, delaying childbirth, single women, etc.). There are two methods for storage of oocytes (unfertilized eggs): slow freezing or vitrification (uses higher concentrations of cryoprotectant and faster cooling rates). Slow freezing is the standard method and has been successful for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. The aim of this study is to examine the rate at which frozen eggs survive freezing and thawing, the rate at which the frozen/thawed eggs fertilize with sperm and the pregnancy outcomes of oocyte (egg) vitrification cycles to determine whether the outcomes are similar or better than standard oocyte (egg) cryopreservation (freezing) cycles.
- Being tested
- slow freeze, Vitrification
- Keywords
- slow freeze, cryopreservation, vitrification, oocyte preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slow freezeProcedure or surgery
Also called Cryopreservation, Traditional freezing, slow freezing
Eggs will be placed in a cryo-protected solution and frozen slowly in a programable freezer
VitrificationProcedure or surgery
Eggs will be placed in a high concentration of cryo-protectant and frozen very quickly by plunging in liquid nitrogen
| Study group | Role | What they receive |
|---|---|---|
| Slow Freezing | Experimental | oocytes will be frozen by slow freeze/ rapid thaw Receives: Procedure: slow freeze |
| Vitrification | Experimental | oocytes will be frozen using rapid freezing/rapid thaw Receives: Procedure: Vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocytes survival after thaw
Whether each oocyte survives the thawing process
Measured: 1 month
Secondary outcomes (2)
Fertilization
Whether each oocyte is successfully fertilized
Measured: 1 month
Implantation
Whether pregnancy occurs.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Diagnosed With CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, MD, HCLD, Study director, RMA of NJKathleen Ferry, BS, Study chair, RMA of NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223105
- Sponsor's protocol ID
- RMA-2009-02
- Status last verified
- Nov 2013
- First submitted
- 8 Oct 2010
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Vitrification of Human Oocytes
- ClinicalTrials.gov ID
- NCT01223105
- Acronym / sponsor ID
- RMA-2009-02
- Keywords
- slow freeze, cryopreservation, vitrification, oocyte preservation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 18 Oct 2010 (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.
This study seeks to evaluate whether the vitrification technique, as compared to the more traditional slow-cooling technique, leads to higher rates of successful thawing, fertilization, implantation and delivery.
Detailed description
Cryopreservation (freezing) of human gametes (unfertilized egg) provides a great potential to preserve or extend fertility in the face of disease and social circumstances (cancer diagnosis, delaying childbirth, single women, etc.). There are two methods for storage of oocytes (unfertilized eggs): slow freezing or vitrification (uses higher concentrations of cryoprotectant and faster cooling rates). Slow freezing is the standard method and has been successful for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. The aim of this study is to examine the rate at which frozen eggs survive freezing and thawing, the rate at which the frozen/thawed eggs fertilize with sperm and the pregnancy outcomes of oocyte (egg) vitrification cycles to determine whether the outcomes are similar or better than standard oocyte (egg) cryopreservation (freezing) cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow Freezing | Experimental | Procedure: slow freezeoocytes will be frozen by slow freeze/ rapid thaw |
| Vitrification | Experimental | Procedure: Vitrificationoocytes will be frozen using rapid freezing/rapid thaw |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 21 and 50 years, at the time of informed consent.
- Subjects must agree to undergo intracytoplasmic sperm injection (ICSI)
Key exclusion criteria (1 listed)
- Presence of any medical condition that contraindicates ovarian stimulation, in vitro fertilization or pregnancy.
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 |
|---|---|---|
| slow freezeAlso: Cryopreservation, Traditional freezing, slow freezingEggs will be placed in a cryo-protected solution and frozen slowly in a programable freezer | Procedure or surgery | Slow Freezing |
| VitrificationEggs will be placed in a high concentration of cryo-protectant and frozen very quickly by plunging in liquid nitrogen | Procedure or surgery | Vitrification |
Primary outcome
Oocytes survival after thaw
Time frame: 1 month
Whether each oocyte survives the thawing process
2 secondary outcomes
Fertilization
Time frame: 1 month
Implantation
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
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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.
Richard T Scott, MD, HCLD study director
RMA of NJ
Kathleen Ferry, BS study chair
RMA of NJ
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing slow freeze and Vitrification in people with Women Diagnosed With Cancer and Egg Donors, run by Reproductive Medicine Associates of New Jersey.
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 2 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: stopped early, as of the sponsor's last update on 19 Nov 2013. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Poor recruitment). Results are not available in the source record.
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?
Oocytes survival after thaw (time frame: 1 month). 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 19 Nov 2013.