Fertility PreservationNCT01696786
Oocyte Cryopreservation
A study testing Oocyte cryopreservation in people with Fertility Preservation, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The specific aim of this study is to further develop methods of oocyte cryopreservation and evaluate their impact on reproductive outcomes. Read more about this study
- Who is it for?
- Ages Up to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Preservation
- What is being tested?
- Oocyte cryopreservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2017
- 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 Up to 42 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Any consenting female who wishes to freeze unfertilized oocytes and are:
- at risk for ovarian hyperstimulation syndrome (enlarged ovaries with abdominal fluid accumulation) and postponement of pregnancy has been recommended.
- a cancer patient anticipating treatment and have been cleared by the oncologists for ovarian stimulation.
- a female who seeks to preserve her future fertility and does not wish to use donor or partner sperm to fertilize her eggs.
- a donor egg recipient who elects to have some of the eggs obtained fertilized with husband/partner sperm and the rest cryopreserved for future use.
- a patient for whom the partner's sperm retrieval or production has failed and donor sperm is not an option.
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- a patient who, for religious or ethical reasons, wants to limit the number of fresh oocytes exposed to sperm (fertilization) and do not want to either discard or donate the excess oocytes.
- AND
- has been clinically and psychologically approved for ovarian stimulation
- age between 12 and 42 years, inclusive, at time of informed consent.
- willing and able to comply with the protocol.
- willing to provide follow-up information from her OB/GYN of any CVS/amniocentesis results, as well as information on obstetrical outcome.
- agree to undergo intracytoplasmic sperm injection (ICSI) when oocytes are thawed.
- For cancer patients:
- No significant ovarian pathology as judged by physical exam and radiological studies;
- Patient's general condition and prognosis deemed favorable for surgery and chemo/radio therapy;
- No other major medical illness,
- Oncologist approval for the ovarian stimulation and egg retrieval.
Who cannot join
- Age > 42 Subjects who do not meet the inclusion criteria will be ineligible for participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
The specific aim of this study is to further develop methods of oocyte cryopreservation and evaluate their impact on reproductive outcomes.
- Conditions
- Fertility Preservation
- Being tested
- Oocyte cryopreservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte cryopreservationProcedure or surgery
Oocyte (egg) cryopreservation (freezing) to preserve fertility
| Study group | Role | What they receive |
|---|---|---|
| Oocyte cryopreservation | Experimental | Not described Receives: Procedure: Oocyte cryopreservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of cryopreserved oocytes with each cryopreservation method
Survival rate of cryopreserved oocytes with each cryopreservation method
Measured: 1 year
Pregnancy rate following thawing/warming of oocytes
Pregnancy rate following thawing/warming of oocytes
Measured: 1 year
Implantation rate per embryo transferred
Implantation rate per embryo transferred
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startJun 2009
- Primary completionOct 2013
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility PreservationStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696786
- Sponsor's protocol ID
- 0903010292
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2012
- Last updated
- 11 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oocyte Cryopreservation
- ClinicalTrials.gov ID
- NCT01696786
- Acronym / sponsor ID
- 0903010292
- Conditions
- Fertility Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 1 Oct 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.
The specific aim of this study is to further develop methods of oocyte cryopreservation and evaluate their impact on reproductive outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oocyte cryopreservation | Experimental | Procedure: Oocyte cryopreservation |
Who may qualify
- Ages
- Up to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- at risk for ovarian hyperstimulation syndrome (enlarged ovaries with abdominal fluid accumulation) and postponement of pregnancy has been recommended.
- a cancer patient anticipating treatment and have been cleared by the oncologists for ovarian stimulation.
- a female who seeks to preserve her future fertility and does not wish to use donor or partner sperm to fertilize her eggs.
- a donor egg recipient who elects to have some of the eggs obtained fertilized with husband/partner sperm and the rest cryopreserved for future use.
- a patient for whom the partner's sperm retrieval or production has failed and donor sperm is not an option.
Key exclusion criteria (1 listed)
- Age > 42 Subjects who do not meet the inclusion criteria will be ineligible for participation in this study.
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 |
|---|---|---|
| Oocyte cryopreservationOocyte (egg) cryopreservation (freezing) to preserve fertility | Procedure or surgery | Oocyte cryopreservation |
Primary outcome
Survival rate of cryopreserved oocytes with each cryopreservation method
Time frame: 1 year
Survival rate of cryopreserved oocytes with each cryopreservation method
Pregnancy rate following thawing/warming of oocytes
Time frame: 1 year
Pregnancy rate following thawing/warming of oocytes
Implantation rate per embryo transferred
Time frame: 1 year
Implantation rate per embryo transferred
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 11 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocyte cryopreservation in people with Fertility Preservation, run by Weill Medical College of Cornell University at 1 site 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 18 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 11 Sep 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 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 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?
Survival rate of cryopreserved oocytes with each cryopreservation method (time frame: 1 year). The study lists 3 primary outcomes in all. 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 11 Sep 2018.