InfertilityNCT00852306
A Comparison of Two Freezing Techniques
A study testing oocyte freezing in people with Infertility, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the best way to freeze eggs in order to preserve the fertility potential of young women. 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
- Infertility
- What is being tested?
- oocyte freezing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2012
- 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 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- donors: women ages 21-32 who wish to donate their eggs; must pass medical, physical and psychological screening.
- recipients: women under the age of 50 who wish to have eggs donated to them through the Donor Egg Program and who aslo pass the medical, physical and psychological screening.
Who cannot join
- donors: those who do not pass the genetic screening or psychological testing, as described below
- recipients: those who do not pass the screening.
- The genetic screening of donors will involve the following:
- All donors will be screened for Cystic Fibrosis, Fragile X and Spinomuscular Atrophy (SMA).
- In addition, donors of Ashkenazi Jewish origin will be screened for Gaucher's disease, Canavan,Tay -Sachs, Familial Dysautonomia, Niemann Pick, Fanconi's Anemia, Bloom and Mucolipidosis Type IV.
- Donors of African-American origin will be screened for Sickle-Cell disease.
Show all 12Show fewer
- Donors of Asian, Mediterranean, Latino or Hispanic origins will be screened for Thalassemia.
- Recipient Screening: A Reproductive Endocrinologist (RE) at the Center will take a detailed history and perform a physical examination on all potential recipients. The RE will assess the health of the potential recipient in order to assess her capacity to carry a pregnancy. Previous IVF cycles, successful or unsuccessful, will have no implication on recipient selection.
- The recipient and her partner (if applicable) will meet with the program psychologist. The psychological evaluation is detailed below.
- Psychological evaluation: A psychological evaluation will be conducted of the Recipient, her partner (if applicable) and the Donor. The purpose of these evaluations is to determine the suitability of the parties to participate in the Donor Egg Program. Psychological tests will be administered by the Center as part of the evaluation process.
- These evaluations may result in a recommendation that one and/or all of the parties not participate in the Donor Egg Program. The psychologist will not be providing any advice or treatment to the Donor or Recipient(s). Nor will the Donor or Recipient(s) be entitled to the results of the Psychologist's evaluation. The Psychologist will provide the results of his/her evaluations to the Center for Human Reproduction.
- As with our standard Donor Egg Program practices, there will be an upper age limit of 50 years for all recipients participating in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
The purpose of this study is to determine the best way to freeze eggs in order to preserve the fertility potential of young women.
Read the detailed description
Human egg freezing is rapidly becoming a vital tool in Assisted Reproductive Technology. Candidates for egg freezing include women without partners who wish to preserve their fertility; cancer patients at risk of losing fertility from chemotherapy; and donor egg recipients. While in the past, egg freezing has not been as successful as embryo freezing in producing live births, recent experience in several centers has demonstrated significant improvement, with pregnancy rates comparable to those achieved with frozen embryos. The purpose of this study is to determine the best method to freeze eggs. We shall be seeking volunteers from the egg donor program, since young, fertile donors represent the best model to study the effect of egg freezing.
We plan to enroll 12 recipients and 6 donors in this study. Each egg donor will go through a stringent screening process (medical, genetic and psychological). Eggs retrieved from all donors will be split in half: one half will be frozen by the slow freeze method, and the other half by vitrification. Each of the six donors will be paired with two recipients; each recipient will be assigned half the total eggs frozen. For each recipient, half of the eggs will come from the slow freeze group and the other half will come from vitrification.
When the recipient's uterine lining is deemed ready (following estrogen treatment and ultrasound monitoring), thawing will be performed on eggs frozen by either the slow freeze or the vitrification method. The thaw process will be randomized between the two types of freezing. One sperm will be injected into each egg that survived the freeze. Fertilization and embryo development will be recorded. Ideally, two embryos will be transferred into the recipient's uterus. Pregnancy will be determined by a blood test and followed by serial blood tests and ultrasound.
The study will determine which freezing method yields better survival and pregnancy rates.
- Conditions
- Infertility
- Being tested
- oocyte freezing
- Keywords
- oocyte freezing, vitrification, slow freeze, fertility preservation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oocyte freezingProcedure or surgery
retrieved oocytes from the donor will be split in half and frozen by both existing egg freezing methods: slow freezing and vitrification. The recipients will then be randomized as to which group of eggs will be thawed out for their first attempt at achieving a pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| slow freeze | Experimental | these recipients will have their first embryo transfer with oocytes frozen via the slow freeze method. Receives: Procedure: oocyte freezing |
| vitrification | Experimental | these recipients will have their first attempt at an embryo transfer with oocytes frozen via the vitrification method. Receives: Procedure: oocyte freezing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of a pregnancy, as determined by a fetal heartbeat
Measured: 2 months
Secondary outcomes (4)
Percentage of eggs that result in blastocyst formation
Measured: 1 week
Oocyte survival (the percentage of eggs that survive the freeze-thaw procedure)
Measured: 2 days
ICSI fertilization rate (percentage of eggs that fertilize)
Measured: 2 days
Incidence rate of embryo formation (percentage of embryos formed/number of eggs fertilized)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- EMD Serono
- Responsible party
- Sponsor
- Investigators
- Avner Hershlag, MD, Principal investigator, Northwell HealthMatthew Cohen, MD, Principal investigator, Northwell HealthHuai L Feng, PhD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852306
- Sponsor's protocol ID
- 08-265
- Status last verified
- Oct 2012
- First submitted
- 25 Feb 2009
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen J, Alikani M, Trowbridge J, Rosenwaks Z. Implantation enhancement by selective assisted hatching using zona drilling of human embryos with poor prognosis. Hum Reprod. 1992 May;7(5):685-91. doi: 10.1093/oxfordjournals.humrep.a137720.
PubMed 1639990Diaz DG, Rodriguez-Karl MC and Moody JE (2007) Human oocyte cryopreservation: preliminary results of survival, fertilization and cleavage rate of frozen oocyte using a new modified slow-freeze protocol. Fertil Steril 88, Suppl 1:S47.
Smith GD, Serafini PC, Fioravanti J, Yadid I, Coslovsky M, Hassun P, Alegretti JR, Motta EL. Prospective randomized comparison of human oocyte cryopreservation with slow-rate freezing or vitrification. Fertil Steril. 2010 Nov;94(6):2088-95. doi: 10.1016/j.fertnstert.2009.12.065. Epub 2010 Feb 19.
PubMed 20171613Fosas N, Marina F, Torres PJ, Jove I, Martin P, Perez N, Arnedo N, Marina S. The births of five Spanish babies from cryopreserved donated oocytes. Hum Reprod. 2003 Jul;18(7):1417-21. doi: 10.1093/humrep/deg297.
PubMed 12832365Gook DA, Edgar DH. Human oocyte cryopreservation. Hum Reprod Update. 2007 Nov-Dec;13(6):591-605. doi: 10.1093/humupd/dmm028. Epub 2007 Sep 10.
PubMed 17846105Hershlag A, Paine T, Kvapil G, Feng H, Napolitano B. In vitro fertilization-intracytoplasmic sperm injection split: an insemination method to prevent fertilization failure. Fertil Steril. 2002 Feb;77(2):229-32. doi: 10.1016/s0015-0282(01)02978-8.
PubMed 11821076Jain JK, Paulson RJ. Oocyte cryopreservation. Fertil Steril. 2006 Oct;86(4 Suppl):1037-46. doi: 10.1016/j.fertnstert.2006.07.1478.
PubMed 17008147Kumayama M and Kato O (2000a) Successful vitrification of human oocytes. Fertil Steril 74, Suppl 3:S49.
Kumayama M and Kato O (2000b) All-round vitrification method for human oocytes and embryos. J Asst Reprod Gen 17:447.
Kuzan FB and Quinn P (1988) Cryopreservation of mammalian embryos IN in vitro fertilization and embryo transfer: a manual of basic techniques. Plenum Press, New York.
Li Y, Feng HL, Cao YJ, Zheng GJ, Yang Y, Mullen S, Critser JK, Chen ZJ. Confocal microscopic analysis of the spindle and chromosome configurations of human oocytes matured in vitro. Fertil Steril. 2006 Apr;85(4):827-32. doi: 10.1016/j.fertnstert.2005.06.064.
PubMed 16580356Nagy ZP, Chang CC, Shapiro DB, Bernal DP, Elsner CW, Mitchell-Leef D, Toledo AA, Kort HI. Clinical evaluation of the efficiency of an oocyte donation program using egg cryo-banking. Fertil Steril. 2009 Aug;92(2):520-6. doi: 10.1016/j.fertnstert.2008.06.005. Epub 2008 Aug 9.
PubMed 18692830Oktay K, Cil AP, Bang H. Efficiency of oocyte cryopreservation: a meta-analysis. Fertil Steril. 2006 Jul;86(1):70-80. doi: 10.1016/j.fertnstert.2006.03.017.
PubMed 16818031Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.
PubMed 1351601Paynter SJ. Current status of the cryopreservation of human unfertilized oocytes. Hum Reprod Update. 2000 Sep-Oct;6(5):449-56. doi: 10.1093/humupd/6.5.449.
PubMed 11045876
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Freezing Techniques
- ClinicalTrials.gov ID
- NCT00852306
- Acronym / sponsor ID
- 08-265
- Conditions
- Infertility
- Keywords
- oocyte freezing, vitrification, slow freeze, fertility preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- EMD Serono
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Feb 2009 (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 purpose of this study is to determine the best way to freeze eggs in order to preserve the fertility potential of young women.
Detailed description
Human egg freezing is rapidly becoming a vital tool in Assisted Reproductive Technology. Candidates for egg freezing include women without partners who wish to preserve their fertility; cancer patients at risk of losing fertility from chemotherapy; and donor egg recipients. While in the past, egg freezing has not been as successful as embryo freezing in producing live births, recent experience in several centers has demonstrated significant improvement, with pregnancy rates comparable to those achieved with frozen embryos. The purpose of this study is to determine the best method to freeze eggs. We shall be seeking volunteers from the egg donor program, since young, fertile donors represent the best model to study the effect of egg freezing.
We plan to enroll 12 recipients and 6 donors in this study. Each egg donor will go through a stringent screening process (medical, genetic and psychological). Eggs retrieved from all donors will be split in half: one half will be frozen by the slow freeze method, and the other half by vitrification. Each of the six donors will be paired with two recipients; each recipient will be assigned half the total eggs frozen. For each recipient, half of the eggs will come from the slow freeze group and the other half will come from vitrification.
When the recipient's uterine lining is deemed ready (following estrogen treatment and ultrasound monitoring), thawing will be performed on eggs frozen by either the slow freeze or the vitrification method. The thaw process will be randomized between the two types of freezing. One sperm will be injected into each egg that survived the freeze. Fertilization and embryo development will be recorded. Ideally, two embryos will be transferred into the recipient's uterus. Pregnancy will be determined by a blood test and followed by serial blood tests and ultrasound.
The study will determine which freezing method yields better survival and pregnancy rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| slow freeze | Experimental | Procedure: oocyte freezingthese recipients will have their first embryo transfer with oocytes frozen via the slow freeze method. |
| vitrification | Experimental | Procedure: oocyte freezingthese recipients will have their first attempt at an embryo transfer with oocytes frozen via the vitrification method. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- donors: women ages 21-32 who wish to donate their eggs; must pass medical, physical and psychological screening.
- recipients: women under the age of 50 who wish to have eggs donated to them through the Donor Egg Program and who aslo pass the medical, physical and psychological screening.
Key exclusion criteria (12 listed)
- donors: those who do not pass the genetic screening or psychological testing, as described below
- recipients: those who do not pass the screening.
- All donors will be screened for Cystic Fibrosis, Fragile X and Spinomuscular Atrophy (SMA).
- In addition, donors of Ashkenazi Jewish origin will be screened for Gaucher's disease, Canavan,Tay -Sachs, Familial Dysautonomia, Niemann Pick, Fanconi's Anemia, Bloom and Mucolipidosis Type IV.
- Donors of African-American origin will be screened for Sickle-Cell disease.
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 freezingretrieved oocytes from the donor will be split in half and frozen by both existing egg freezing methods: slow freezing and vitrification. The recipients will then be randomized as to which group of eggs will be thawed out for their first attempt at achieving a pregnancy. | Procedure or surgery | slow freeze, vitrification |
Primary outcome
Achievement of a pregnancy, as determined by a fetal heartbeat
Time frame: 2 months
4 secondary outcomes
Percentage of eggs that result in blastocyst formation
Time frame: 1 week
Oocyte survival (the percentage of eggs that survive the freeze-thaw procedure)
Time frame: 2 days
ICSI fertilization rate (percentage of eggs that fertilize)
Time frame: 2 days
Incidence rate of embryo formation (percentage of embryos formed/number of eggs fertilized)
Time frame: 2 days
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 10 Oct 2012.
- Background: PubMed 1639990Cohen J, Alikani M, Trowbridge J, Rosenwaks Z. Implantation enhancement by selective assisted hatching using zona drilling of human embryos with poor prognosis. Hum Reprod. 1992 May;7(5):685-91. doi: 10.1093/oxfordjournals.humrep.a137720.
- BackgroundDiaz DG, Rodriguez-Karl MC and Moody JE (2007) Human oocyte cryopreservation: preliminary results of survival, fertilization and cleavage rate of frozen oocyte using a new modified slow-freeze protocol. Fertil Steril 88, Suppl 1:S47.
- Background: PubMed 20171613Smith GD, Serafini PC, Fioravanti J, Yadid I, Coslovsky M, Hassun P, Alegretti JR, Motta EL. Prospective randomized comparison of human oocyte cryopreservation with slow-rate freezing or vitrification. Fertil Steril. 2010 Nov;94(6):2088-95. doi: 10.1016/j.fertnstert.2009.12.065. Epub 2010 Feb 19.
- Background: PubMed 12832365Fosas N, Marina F, Torres PJ, Jove I, Martin P, Perez N, Arnedo N, Marina S. The births of five Spanish babies from cryopreserved donated oocytes. Hum Reprod. 2003 Jul;18(7):1417-21. doi: 10.1093/humrep/deg297.
- Background: PubMed 17846105Gook DA, Edgar DH. Human oocyte cryopreservation. Hum Reprod Update. 2007 Nov-Dec;13(6):591-605. doi: 10.1093/humupd/dmm028. Epub 2007 Sep 10.
- Background: PubMed 11821076Hershlag A, Paine T, Kvapil G, Feng H, Napolitano B. In vitro fertilization-intracytoplasmic sperm injection split: an insemination method to prevent fertilization failure. Fertil Steril. 2002 Feb;77(2):229-32. doi: 10.1016/s0015-0282(01)02978-8.
- Background: PubMed 17008147Jain JK, Paulson RJ. Oocyte cryopreservation. Fertil Steril. 2006 Oct;86(4 Suppl):1037-46. doi: 10.1016/j.fertnstert.2006.07.1478.
- BackgroundKumayama M and Kato O (2000a) Successful vitrification of human oocytes. Fertil Steril 74, Suppl 3:S49.
- BackgroundKumayama M and Kato O (2000b) All-round vitrification method for human oocytes and embryos. J Asst Reprod Gen 17:447.
- BackgroundKuzan FB and Quinn P (1988) Cryopreservation of mammalian embryos IN in vitro fertilization and embryo transfer: a manual of basic techniques. Plenum Press, New York.
- Background: PubMed 16580356Li Y, Feng HL, Cao YJ, Zheng GJ, Yang Y, Mullen S, Critser JK, Chen ZJ. Confocal microscopic analysis of the spindle and chromosome configurations of human oocytes matured in vitro. Fertil Steril. 2006 Apr;85(4):827-32. doi: 10.1016/j.fertnstert.2005.06.064.
- Background: PubMed 18692830Nagy ZP, Chang CC, Shapiro DB, Bernal DP, Elsner CW, Mitchell-Leef D, Toledo AA, Kort HI. Clinical evaluation of the efficiency of an oocyte donation program using egg cryo-banking. Fertil Steril. 2009 Aug;92(2):520-6. doi: 10.1016/j.fertnstert.2008.06.005. Epub 2008 Aug 9.
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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.
Avner Hershlag, MD principal investigator
Northwell Health
Matthew Cohen, MD principal investigator
Northwell Health
Huai L Feng, PhD principal investigator
Northwell Health
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 freezing in people with Infertility, run by Northwell Health 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 2 inclusion and 12 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 10 Oct 2012. 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?
Achievement of a pregnancy, as determined by a fetal heartbeat (time frame: 2 months). 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 NCT00852306, which also lists 21 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 10 Oct 2012.