InfertilityNCT02068924
Vitrification and Slow Freezing for Cryopreservation of Blastocyst
A study testing Slow freezing versus vitrification in people with Infertility, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo… Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Slow freezing versus vitrification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Mar 2018
- 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 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- woman < 36 years old
- first IVF or ICSI attempt with ejaculated sperm
- at least 5 ovocytes at the pick up
- at least 3 top embryos at day-2
- at least one supernumerary blastocyst with good quality at day-5 or day-6
Who cannot join
- - woman : FSH >12UI/l
- ICSI with epididymal or testicular spermatozoa
- None supernumerary blastocyst with good quality at day-5 or day-6
- Refuse by the couple to have an embryo transfer at day-5
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-celrmontferrand.fr
About this study
Official title: Single Embryo Transfer: Comparison of Slow Freezing and Vitrification at Blastocyst Stage
Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo quality. The policy of transferring more than one embryo after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies reported in Europe and United States over the past 15 years. These multiple pregnancies are the main disadvantage of ART because of their negative impact on obstetrical, neonatal and economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of development at the cleavage stage. With the development of physiologically-based sequential culture media, it has also been suggested that extending embryo culture to Day-5 in order to transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy. Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.
However a recent embryo freezing technique (vitrification) seems to show significant higher pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications have reported the outcome of single embryo transfer at blastocyst stage by a prospective randomized and comparative study including the results of fresh and frozen/thawed blastocyst by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .
Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.
Read the detailed description
Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo quality. The policy of transferring more than one embryo after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies reported in Europe and United States over the past 15 years. These multiple pregnancies are the main disadvantage of ART because of their negative impact on obstetrical, neonatal and economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of development at the cleavage stage. With the development of physiologically-based sequential culture media, it has also been suggested that extending embryo culture to Day-5 in order to transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy. Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.
However a recent embryo freezing technique (vitrification) seems to show significant higher pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications have reported the outcome of single embryo transfer at blastocyst stage by a prospective randomized and comparative study including the results of fresh and frozen/thawed blastocyst by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .
Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.
- Conditions
- Infertility
- Being tested
- Slow freezing versus vitrification
- Keywords
- Slow freezing, Vitrification, Single embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow freezing versus vitrificationOther
Also called Slow freezing:, G Freeze Kit Blast, Vitrolife, Suede, G-Thaw-kit Blast, Vitrolife, Suede, Vitrification:
| Study group | Role | What they receive |
|---|---|---|
| slow freezing | Experimental | Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure. Receives: Other: Slow freezing versus vitrification |
| vitrification | Other | Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure. Receives: Other: Slow freezing versus vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative delivery rate after fresh and frozen/thawed embryo transfers
Measured: 9 months after embryo transfer
Secondary outcomes (4)
Delivery rate after fresh embryo transfer
Measured: 9 months after embryo transfer
Delivery rate after transfer of frozen embryos (slow freezing)
Measured: 9 months after embryo transfer
Delivery rate after transfer of frozen embryos (vitrification)
Measured: 9 months after embryo transfer
Neonatal outcome
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 posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
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.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Vitrolife
- Responsible party
- Sponsor
- Investigators
- Brugnon Florence, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068924
- Sponsor's protocol ID
- CHU-0181
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Embryo Transfer: Comparison of Slow Freezing and Vitrification at Blastocyst Stage
- ClinicalTrials.gov ID
- NCT02068924
- Acronym / sponsor ID
- CHU-0181
- Conditions
- Infertility
- Keywords
- Slow freezing, Vitrification, Single embryo transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Vitrolife
- Study start
- Feb 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 21 Feb 2014 (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.
Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo quality. The policy of transferring more than one embryo after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies reported in Europe and United States over the past 15 years. These multiple pregnancies are the main disadvantage of ART because of their negative impact on obstetrical, neonatal and economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of development at the cleavage stage. With the development of physiologically-based sequential culture media, it has also been suggested that extending embryo culture to Day-5 in order to transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy. Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.
However a recent embryo freezing technique (vitrification) seems to show significant higher pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications have reported the outcome of single embryo transfer at blastocyst stage by a prospective randomized and comparative study including the results of fresh and frozen/thawed blastocyst by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .
Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.
Detailed description
Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo quality. The policy of transferring more than one embryo after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies reported in Europe and United States over the past 15 years. These multiple pregnancies are the main disadvantage of ART because of their negative impact on obstetrical, neonatal and economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of development at the cleavage stage. With the development of physiologically-based sequential culture media, it has also been suggested that extending embryo culture to Day-5 in order to transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy. Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.
However a recent embryo freezing technique (vitrification) seems to show significant higher pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications have reported the outcome of single embryo transfer at blastocyst stage by a prospective randomized and comparative study including the results of fresh and frozen/thawed blastocyst by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .
Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| slow freezing | Experimental | Other: Slow freezing versus vitrificationTherefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure. |
| vitrification | Other | Other: Slow freezing versus vitrificationTherefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- woman < 36 years old
- first IVF or ICSI attempt with ejaculated sperm
- at least 5 ovocytes at the pick up
- at least 3 top embryos at day-2
- at least one supernumerary blastocyst with good quality at day-5 or day-6
Key exclusion criteria (4 listed)
- - woman : FSH >12UI/l
- ICSI with epididymal or testicular spermatozoa
- None supernumerary blastocyst with good quality at day-5 or day-6
- Refuse by the couple to have an embryo transfer at day-5
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 freezing versus vitrificationAlso: Slow freezing:, G Freeze Kit Blast, Vitrolife, Suede, G-Thaw-kit Blast, Vitrolife, Suede, Vitrification: | Other | slow freezing, vitrification |
Primary outcome
Cumulative delivery rate after fresh and frozen/thawed embryo transfers
Time frame: 9 months after embryo transfer
4 secondary outcomes
Delivery rate after fresh embryo transfer
Time frame: 9 months after embryo transfer
Delivery rate after transfer of frozen embryos (slow freezing)
Time frame: 9 months after embryo transfer
Delivery rate after transfer of frozen embryos (vitrification)
Time frame: 9 months after embryo transfer
Neonatal outcome
Time frame: 9 months after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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.
Brugnon Florence principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow freezing versus vitrification in people with Infertility, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Feb 2014. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative delivery rate after fresh and frozen/thawed embryo transfers (time frame: 9 months after embryo transfer). 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 Feb 2014.