FertilizationNCT01223118
Evaluation of the Impact of Vitrification on Oocytes
A study testing Vitrification and PGD in people with Fertilization, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
Trial summary
The purpose of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fertilization
- What is being tested?
- Vitrification and PGD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Jul 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No prior failed IVF treatment cycle
- Female partner less than 35 years of age at time of onset of the IVF cycle
- Normal maximum prior day 3 follicle stimulating hormone (FSH) level (< or = 10 IU/L)
- Total basal antral follicle count greater than or equal to 12
- Male partner with greater than 100,000 total motile spermatozoa Donor sperm is acceptable but the couples will be required to provide one additional vial for DNA analysis
- Body Mass Index (BMI) ≤ 32 kg/m2
Who cannot join
- Diagnosis of chronic oligoovulation or anovulation (cycle typically occurring less often than every 38 days)
- Diagnosis of endometrial insufficiency
- Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
- Use of testicular aspiration or biopsy procedures to obtain sperm
- Unevaluated ovarian mass
- Presence of hydrosalpinges which communicate with the endometrial cavity
- Any contraindication to undergoing in vitro fertilization or gonadotropin stimulation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Reproductive Medicine Assoicates of PA at Lehigh Valley
Allentown, Pennsylvania, 18104
Reproductive Medicine Associates of New Jersey
Morristown, New Jersey, 07960
About this study
Official title: Evaluation of the Impact of Vitrification on the Reproductive Performance and Potential of Human Oocytes
The purpose of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.
Read the detailed description
This study will recruit patients from the NY/NJ/CT/eastern PA area only.
Cryopreservation of human oocytes has a great potential to preserve or extend fertility in the face of disease whose treatment would result in a loss of ovarian function. (malignancy, severe autoimmune disease, etc.). It would also provide a means of quarantining oocytes to be used in oocyte donation to provide the lowest possible risk of infection.
There are two methods for storage of oocytes: slow freezing or vitrification. Slow freezing is the conventional method and has been successfully used for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. However, the technique has not been rigorously validated to date. The aim of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.
Patients will undergo ovarian stimulation for in vitro fertilization (IVF) according to the protocol recommended by their primary doctor. After retrieval, mature oocytes will be divided in half. One half will undergo vitrification, immediate thaw and intracytoplasmic sperm injection (ICSI). The other half will undergo just ICSI. All embryos will then develop on identical culture until day 3 or day 5. Prior to transfer, the best embryo from each group will undergo biopsy for genetic fingerprinting. The patient will have a 2 embryo transfer (one from each group). All extra embryos will be biopsied for pre-implantation genetic diagnosis (PGD) prior to being cryopreserved. If the patient becomes pregnant, we will follow up with an additional blood draw at approximately 9 weeks gestation and buccal swabs after the delivery of the infant(s).
- Conditions
- Fertilization
- Being tested
- Vitrification and PGD
- Keywords
- Oocyte, vitrification, IVF, PGD, embryo biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrification and PGDProcedure or surgery
Also called Vitrification, PGD
Half of the oocytes retrieved from each patient will undergo vitrification, immediate thaw and insemination. All embryos will undergo biopsy for PGD prior to transfer.
| Study group | Role | What they receive |
|---|---|---|
| Oocyte Vitrification | Experimental | Each patient will have oocytes randomized into two groups immediately after retrieval. Half of oocytes will be vitrified, thawed and inseminated. The other half will be inseminated only. All embryos will be biopsied for PGD prior to transfer and one embryo from each group will be transferred (vitrification and control groups). Following delivery, buccal swabs will be collected on all infants. Receives: Procedure: Vitrification and PGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneuploidy Rate (evaluation of whether embryo is chromosomally normal)
Compare the rate of chromosomally-abnormal embryos among embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.
Measured: 1 year
Secondary outcomes (2)
Delivery rates
All embryos will be biopsied prior to transfer and DNA samples will be collected from all infants. Compare embryonic and infant DNA to evaluate whether the live birth resulted from a vitrified or a fresh/control oocyte.
Measured: 1 year
Paired Sustained Implantation Rate (number of viable fetuses beyond the first trimester per embryo transferred)
Among patients with a paired two blastocyst transfer, compare the implantation rate of embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.
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 posted18 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilizationStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 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, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223118
- Sponsor's protocol ID
- RMA-2010-02
- Status last verified
- Jan 2013
- First submitted
- 8 Oct 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Vitrification on the Reproductive Performance and Potential of Human Oocytes
- ClinicalTrials.gov ID
- NCT01223118
- Acronym / sponsor ID
- RMA-2010-02
- Conditions
- Fertilization
- Keywords
- Oocyte, vitrification, IVF, PGD, embryo biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (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.
The purpose of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.
Detailed description
This study will recruit patients from the NY/NJ/CT/eastern PA area only.
Cryopreservation of human oocytes has a great potential to preserve or extend fertility in the face of disease whose treatment would result in a loss of ovarian function. (malignancy, severe autoimmune disease, etc.). It would also provide a means of quarantining oocytes to be used in oocyte donation to provide the lowest possible risk of infection.
There are two methods for storage of oocytes: slow freezing or vitrification. Slow freezing is the conventional method and has been successfully used for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. However, the technique has not been rigorously validated to date. The aim of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.
Patients will undergo ovarian stimulation for in vitro fertilization (IVF) according to the protocol recommended by their primary doctor. After retrieval, mature oocytes will be divided in half. One half will undergo vitrification, immediate thaw and intracytoplasmic sperm injection (ICSI). The other half will undergo just ICSI. All embryos will then develop on identical culture until day 3 or day 5. Prior to transfer, the best embryo from each group will undergo biopsy for genetic fingerprinting. The patient will have a 2 embryo transfer (one from each group). All extra embryos will be biopsied for pre-implantation genetic diagnosis (PGD) prior to being cryopreserved. If the patient becomes pregnant, we will follow up with an additional blood draw at approximately 9 weeks gestation and buccal swabs after the delivery of the infant(s).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oocyte Vitrification | Experimental | Procedure: Vitrification and PGDEach patient will have oocytes randomized into two groups immediately after retrieval. Half of oocytes will be vitrified, thawed and inseminated. The other half will be inseminated only. All embryos will be biopsied for PGD prior to transfer and one embryo from each group will be transferred (vitrification and control groups). Following delivery, buccal swabs will be collected on all infants. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- No prior failed IVF treatment cycle
- Female partner less than 35 years of age at time of onset of the IVF cycle
- Normal maximum prior day 3 follicle stimulating hormone (FSH) level (< or = 10 IU/L)
- Total basal antral follicle count greater than or equal to 12
- Male partner with greater than 100,000 total motile spermatozoa Donor sperm is acceptable but the couples will be required to provide one additional vial for DNA analysis
Key exclusion criteria (7 listed)
- Diagnosis of chronic oligoovulation or anovulation (cycle typically occurring less often than every 38 days)
- Diagnosis of endometrial insufficiency
- Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
- Use of testicular aspiration or biopsy procedures to obtain sperm
- Unevaluated ovarian mass
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 |
|---|---|---|
| Vitrification and PGDAlso: Vitrification, PGDHalf of the oocytes retrieved from each patient will undergo vitrification, immediate thaw and insemination. All embryos will undergo biopsy for PGD prior to transfer. | Procedure or surgery | Oocyte Vitrification |
Primary outcome
Aneuploidy Rate (evaluation of whether embryo is chromosomally normal)
Time frame: 1 year
Compare the rate of chromosomally-abnormal embryos among embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.
2 secondary outcomes
Delivery rates
Time frame: 1 year
Paired Sustained Implantation Rate (number of viable fetuses beyond the first trimester per embryo transferred)
Time frame: 1 year
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 23 Jan 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 principal investigator
Reproductive Medicine Associates of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrification and PGD in people with Fertilization, run by Reproductive Medicine Associates of New Jersey 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 6 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: finished, as of the sponsor's last update on 23 Jan 2013. 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 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?
Aneuploidy Rate (evaluation of whether embryo is chromosomally normal) (time frame: 1 year). 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 23 Jan 2013.