InfertilityNCT01481571
Performance Study of New Media for Vitrification of Human Oocytes
A study testing Vitrification medium oocyte, warming medium oocyte and Rapid-i in people with Infertility, run by Vitrolife at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte vitrification/warming media and the vitrification device Rapid-i™, when using vitrification as a cryopreservation method for human oocytes. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Vitrification medium oocyte, warming medium oocyte and Rapid-i
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Sep 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Couple agreed to participate in study and has signed the Informed Consent Document before any study-related activities
- Patient age (female): 18-37 years (including oocyte donors)
- BMI 18-27 kg/m2 (female)
- 2 ovaries, normal uterine cavity (female)
- Day 3 FSH ≤ 10mIU, E2 <80 pg/mL and an AFC ≥12 (both ovaries, 3 mm or greater) (female)
- AMH >1 (female)
Show all 10Show fewer
- Ejaculatory sperm (male)
- ICSI fertilization
- Long standard stimulation protocol
- English speaking
Who cannot join
- Previous participation in the study
- ≥2 previous failed IVF cycles
- Endometrioma
- Presence of a hydrosalpinx
- History of recurrent miscarriage (defined as ≥2 clinical recognized SABs)
- Not willing to have ICSI performed
- Cycle length >6 weeks [a diagnosis of PCOS will not exclude from the study unless typical cycle length is greater than 6 weeks; this criteria would exclude hypothalamic-hypogonadotropic patients]
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The DFW Fertility Associates, Reproductive Endocrinology and Infertility, Dallas Fertility Centre
Dallas, Texas, 75231
Frisco IVF
Frisco, Texas, 75034
About this study
The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte vitrification/warming media and the vitrification device Rapid-i™, when using vitrification as a cryopreservation method for human oocytes.
Read the detailed description
A multi-center prospective sibling oocyte vitrification trial where, in the first phase, half of the patients' oocytes will be vitrified and warmed (experimental group). The remaining oocytes will not be vitrified and will serve as the control group. In the second phase all of the patients' oocytes will be vitrified and the embryo transfer will be performed in a following cycle. This simulates the situation of a normal cryopreservation embryo transfer. The study population consists of 20 women who will undergo a fresh IVF cycle during the study period. The primary objective in the first phase is to assess survival, fertilization and embryo development after oocyte vitrification/warming with the new media. The results will be compared with results from sibling oocytes which have not been vitrified. Secondary objectives are to assess the clinical results such as implantation, miscarriage and pregnancy rate as well as delivery rate and neonatal outcome.
The primary objective in the second phase is to assess the delivery rate after oocyte vitrification/warming with the new media. Secondary objectives are to assess survival, fertilization, embryo development, utilization rate, pregnancy rate and neonatal outcome on the previously vitrified and warmed oocytes. The results will be compared with results from a control group of patients, treated at the same clinics within the same time period, using the same inclusion and exclusion criteria. All patients who undergo embryo transfer will have a serum beta-hCG test conducted 14 days after oocyte retrieval. If positive, repeat beta-hCG testing will be conducted 2-4 days later. If appropriate, a pregnancy ultrasound will be conducted between 6-8 weeks gestation (menstrual age) to record gestational sac(s) and fetal heart beat. The delivery outcome will also be recorded. For patients with an unsuccessful treatment, there will be a follow-up period of 6 months after study completion. From this follow-up, data from frozen cycles, i.e. from embryos after oocyte vitrification, can be evaluated as well.
- Conditions
- Infertility
- Being tested
- Vitrification medium oocyte, warming medium oocyte and Rapid-i
- Keywords
- Media for vitrification/warming of human oocytes
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrification medium oocyte, warming medium oocyte and Rapid-iDevice
Media and device for vitrification of human oocytes
| Study group | Role | What they receive |
|---|---|---|
| Vitrification media and device | Experimental | Vitrification medium oocyte, warming medium oocyte and Rapid-i Receives: Device: Vitrification medium oocyte, warming medium oocyte and Rapid-i |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo development after oocyte vitrification/warming.
Embryo development, as number of good quality blastocysts, after oocyte vitrification and warming.
Measured: 5 days after oocyte retrieval
Secondary outcomes (3)
Implantation rate of previously vitrified/warmed oocytes.
Number of embryos implanted. Expressed as a percentage of number transferred.
Measured: 4 weeks after embryo transfer
Ongoing pregnancy rate
Number of ongoing pregnancies at 3months. Expressed as a percentage of patients undergoing embryo transfer.
Measured: 3 months after embryo transfer
Live birth
Number of lives births results from embryos transferred.
Measured: 9 months after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionSep 2012
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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitrolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marius Meintjes, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481571
- Sponsor's protocol ID
- Vitrolife-oocyte-vitri 01
- Status last verified
- Feb 2014
- First submitted
- 18 Nov 2011
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Study of New Media for Vitrification of Human Oocytes
- ClinicalTrials.gov ID
- NCT01481571
- Acronym / sponsor ID
- Vitrolife-oocyte-vitri 01
- Conditions
- Infertility
- Keywords
- Media for vitrification/warming of human oocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VitrolifeIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Nov 2011 (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 evaluate safety and performance of Vitrolife´s new oocyte vitrification/warming media and the vitrification device Rapid-i™, when using vitrification as a cryopreservation method for human oocytes.
Detailed description
A multi-center prospective sibling oocyte vitrification trial where, in the first phase, half of the patients' oocytes will be vitrified and warmed (experimental group). The remaining oocytes will not be vitrified and will serve as the control group. In the second phase all of the patients' oocytes will be vitrified and the embryo transfer will be performed in a following cycle. This simulates the situation of a normal cryopreservation embryo transfer. The study population consists of 20 women who will undergo a fresh IVF cycle during the study period. The primary objective in the first phase is to assess survival, fertilization and embryo development after oocyte vitrification/warming with the new media. The results will be compared with results from sibling oocytes which have not been vitrified. Secondary objectives are to assess the clinical results such as implantation, miscarriage and pregnancy rate as well as delivery rate and neonatal outcome.
The primary objective in the second phase is to assess the delivery rate after oocyte vitrification/warming with the new media. Secondary objectives are to assess survival, fertilization, embryo development, utilization rate, pregnancy rate and neonatal outcome on the previously vitrified and warmed oocytes. The results will be compared with results from a control group of patients, treated at the same clinics within the same time period, using the same inclusion and exclusion criteria. All patients who undergo embryo transfer will have a serum beta-hCG test conducted 14 days after oocyte retrieval. If positive, repeat beta-hCG testing will be conducted 2-4 days later. If appropriate, a pregnancy ultrasound will be conducted between 6-8 weeks gestation (menstrual age) to record gestational sac(s) and fetal heart beat. The delivery outcome will also be recorded. For patients with an unsuccessful treatment, there will be a follow-up period of 6 months after study completion. From this follow-up, data from frozen cycles, i.e. from embryos after oocyte vitrification, can be evaluated as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitrification media and device | Experimental | Device: Vitrification medium oocyte, warming medium oocyte and Rapid-iVitrification medium oocyte, warming medium oocyte and Rapid-i |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Couple agreed to participate in study and has signed the Informed Consent Document before any study-related activities
- Patient age (female): 18-37 years (including oocyte donors)
- BMI 18-27 kg/m2 (female)
- 2 ovaries, normal uterine cavity (female)
- Day 3 FSH ≤ 10mIU, E2 <80 pg/mL and an AFC ≥12 (both ovaries, 3 mm or greater) (female)
Key exclusion criteria (7 listed)
- Previous participation in the study
- ≥2 previous failed IVF cycles
- Endometrioma
- Presence of a hydrosalpinx
- History of recurrent miscarriage (defined as ≥2 clinical recognized SABs)
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 medium oocyte, warming medium oocyte and Rapid-iMedia and device for vitrification of human oocytes | Device | Vitrification media and device |
Primary outcome
Embryo development after oocyte vitrification/warming.
Time frame: 5 days after oocyte retrieval
Embryo development, as number of good quality blastocysts, after oocyte vitrification and warming.
3 secondary outcomes
Implantation rate of previously vitrified/warmed oocytes.
Time frame: 4 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: 3 months after embryo transfer
Live birth
Time frame: 9 months after embryo transfer
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 24 Mar 2014.
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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.
Marius Meintjes, Dr principal investigator
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 medium oocyte, warming medium oocyte and Rapid-i in people with Infertility, run by Vitrolife 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 10 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 24 Mar 2014. 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?
Embryo development after oocyte vitrification/warming. (time frame: 5 days after oocyte retrieval). 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 24 Mar 2014.