InfertilityNCT02652143
Does in Vivo Culture of Pre-cleavage Stage Embryo Reduce the Incidence of Aneuploidy?
A study testing AneVivo (Medical device for in vivo culture of embryos) and comparator for embryo culture in vitro in people with Infertility and Reproductive Sterility, run by Anecova SA at 1 site in Spain.
Trial summary
This Clinical Study has been designed to assess and compare the impact of in vitro or in vivo culture conditions on the euploidy of sibling blastocysts. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Reproductive Sterility
- What is being tested?
- AneVivo (Medical device for in vivo culture of embryos) and comparator for embryo culture in vitro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Jun 2016
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed Informed Consent by the subject and her partner
- Women, aged between 18 and 38 years (up to 38th birthday)
- ≤ 2 previous stimulation cycles
- Routinely measured hormonal levels within normal range (i.e. FSH, LH, E2, PRL)
- No uterine or ovarian anatomical abnormalities and/or alterations that would compromise device delivery or function in the uterus as demonstrated by ultrasound and trial insertion
- 19 ≤ BMI ≤ 29 kg/m2
Who cannot join
- History of previous moderate or severe ovarian hyperstimulation syndrome (OHSS)
- Severe endometriosis
- Any active infection that would contraindicate ART, at the discretion of the investigator
- Severe male factor in the partner (cryptozoospermia or non-obstructive azoospermia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does in Vivo Culture of Pre-cleavage Stage Embryo Reduce the Incidence of Aneuploidy? A Sibling Oocyte, Prospective, Multi-centric, Randomized, Open Study, Clinical Study in Subjects With Subfertility Undergoing Assisted Reproductive Medical Treatment
This Clinical Study has been designed to assess and compare the impact of in vitro or in vivo culture conditions on the euploidy of sibling blastocysts.
Read the detailed description
As soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place.
These biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female DNA and the chromosome segregation on the newly formed mitotic spindle.
If any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. In other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy.
In vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions.
Preliminary data from the pilot study have shown a higher proportion of euploid embryos for sibling oocytes cultured in vivo vs. in vitro. Moreover, in animal models, in vivo cultured embryos have been described with significant reduction of aneuploidies and with differences in the gene expression levels patterns when compared to in vitro cultured embryos. There is also growing evidence that the culture conditions of human pre-implantation embryos can affect the gene expression regulation with measurable effects on embryos and on newborn children.
The investigators hypothesis is that in vivo produced embryos might have a higher percentage of euploidy when compared to their siblings cultured in vitro.
- Conditions
- Infertility, Reproductive Sterility
- Being tested
- AneVivo (Medical device for in vivo culture of embryos), comparator for embryo culture in vitro
- Keywords
- in vivo culture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AneVivo (Medical device for in vivo culture of embryos)Device
Also called Anecova
comparator for embryo culture in vitroOther
| Study group | Role | What they receive |
|---|---|---|
| sibling oocytes in vivo | Experimental | randomized oocytes assigned to in vivo culture Receives: Device: AneVivo (Medical device for in vivo culture of embryos) |
| sibling oocyte in vitro | Active comparator | randomized oocytes assigned to in vitro culture Receives: Other: comparator for embryo culture in vitro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euploidy status after a biopsy on all viable day 5 embryos
full genome analysis on 24 chromosomes
Measured: 1 week
Secondary outcomes (2)
Implantation rate
number of gestational sac per transferred embryos
Measured: 9 weeks
Pregnancy rate
beating heart
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionJun 2016
Why it stopped: Terminated due to difficult recruitment
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anecova SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcos Ferrando, MD, Principal investigator, IVI Bilbao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652143
- Sponsor's protocol ID
- NCVd20H
- Status last verified
- Apr 2019
- First submitted
- 7 Jan 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does in Vivo Culture of Pre-cleavage Stage Embryo Reduce the Incidence of Aneuploidy? A Sibling Oocyte, Prospective, Multi-centric, Randomized, Open Study, Clinical Study in Subjects With Subfertility Undergoing Assisted Reproductive Medical Treatment
- ClinicalTrials.gov ID
- NCT02652143
- Acronym / sponsor ID
- NCVd20H
- Conditions
- Infertility, Reproductive Sterility
- Keywords
- in vivo culture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to difficult recruitment
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Anecova SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Jan 2016 (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.
This Clinical Study has been designed to assess and compare the impact of in vitro or in vivo culture conditions on the euploidy of sibling blastocysts.
Detailed description
As soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place.
These biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female DNA and the chromosome segregation on the newly formed mitotic spindle.
If any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. In other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy.
In vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions.
Preliminary data from the pilot study have shown a higher proportion of euploid embryos for sibling oocytes cultured in vivo vs. in vitro. Moreover, in animal models, in vivo cultured embryos have been described with significant reduction of aneuploidies and with differences in the gene expression levels patterns when compared to in vitro cultured embryos. There is also growing evidence that the culture conditions of human pre-implantation embryos can affect the gene expression regulation with measurable effects on embryos and on newborn children.
The investigators hypothesis is that in vivo produced embryos might have a higher percentage of euploidy when compared to their siblings cultured in vitro.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sibling oocytes in vivo | Experimental | Device: AneVivo (Medical device for in vivo culture of embryos)randomized oocytes assigned to in vivo culture |
| sibling oocyte in vitro | Active comparator | Other: comparator for embryo culture in vitrorandomized oocytes assigned to in vitro culture |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed Informed Consent by the subject and her partner
- Women, aged between 18 and 38 years (up to 38th birthday)
- ≤ 2 previous stimulation cycles
- Routinely measured hormonal levels within normal range (i.e. FSH, LH, E2, PRL)
- No uterine or ovarian anatomical abnormalities and/or alterations that would compromise device delivery or function in the uterus as demonstrated by ultrasound and trial insertion
Key exclusion criteria (4 listed)
- History of previous moderate or severe ovarian hyperstimulation syndrome (OHSS)
- Severe endometriosis
- Any active infection that would contraindicate ART, at the discretion of the investigator
- Severe male factor in the partner (cryptozoospermia or non-obstructive azoospermia)
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 |
|---|---|---|
| AneVivo (Medical device for in vivo culture of embryos)Also: Anecova | Device | sibling oocytes in vivo |
| comparator for embryo culture in vitro | Other | sibling oocyte in vitro |
Primary outcome
Euploidy status after a biopsy on all viable day 5 embryos
Time frame: 1 week
full genome analysis on 24 chromosomes
2 secondary outcomes
Implantation rate
Time frame: 9 weeks
Pregnancy rate
Time frame: 9 weeks
Results and safety
The study was stopped early (reason given: Terminated due to difficult recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Marcos Ferrando, MD principal investigator
IVI Bilbao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AneVivo (Medical device for in vivo culture of embryos) and comparator for embryo culture in vitro in people with Infertility and Reproductive Sterility, run by Anecova SA at 1 site in Spain.
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 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: stopped early, as of the sponsor's last update on 4 Apr 2019. 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 Spain. 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 was stopped early (reason given: Terminated due to difficult recruitment). Results are not available in the source record.
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?
Euploidy status after a biopsy on all viable day 5 embryos (time frame: 1 week). 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 4 Apr 2019.