Embryo Diagnosis and SelectionNCT01549262
Clinical Validation of Embryo Cinematography
A study testing Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673) and Observe embryo development in people with Embryo Diagnosis and Selection, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether the multivariable model for embryo selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison with standard incubator and an embryo selection… 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
- Embryo Diagnosis and Selection
- What is being tested?
- Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673) and Observe embryo development
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 843 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Jul 2013
- 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
- Female patients undergoing assisted reproduction with ICSI, first or second cycle
- 20 to 38 yers old
- BMI (18-25)
- No endometriosis,
- > 6 Metaphse II oocytes
- Basal FSH < 12 UI
- AMH > 7pmol/L
Who cannot join
- Hydrosalpinx
- Recurrent pregnancy loss
- Severe male factor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of Embryo Culture and Selection by Morphokinetic Analysis; a Randomized Controlled Trial by Time-lapse System
The purpose of this study is to determine whether the multivariable model for embryo selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison with standard incubator and an embryo selection process based exclusively in morphology.
- Conditions
- Embryo Diagnosis and Selection
- Being tested
- Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673), Observe embryo development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)Device
Observation of exact timing of embryo cleavages together with other morphology dynamics parameters.
Observe embryo developmentDevice
Observe embryo development in the traditional manner
| Study group | Role | What they receive |
|---|---|---|
| Standard Incubator | Active comparator | Not described Receives: Device: Observe embryo development |
| ESD Time-lapse Monitoring system | Experimental | Not described Receives: Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy Rate
Measured: confirmed 16-18 weeks 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 posted9 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Embryo Diagnosis and SelectionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Meseguer, Instituto Valenciano de Infertilidad, IVI VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549262
- Sponsor's protocol ID
- 1009-C-088-IR
- Status last verified
- Aug 2014
- First submitted
- 16 Feb 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Insua MF, Cobo AC, Larreategui Z, Ferrando M, Serra V, Meseguer M. Obstetric and perinatal outcomes of pregnancies conceived with embryos cultured in a time-lapse monitoring system. Fertil Steril. 2017 Sep;108(3):498-504. doi: 10.1016/j.fertnstert.2017.06.031.
PubMed 28865550Rubio I, Galan A, Larreategui Z, Ayerdi F, Bellver J, Herrero J, Meseguer M. Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope. Fertil Steril. 2014 Nov;102(5):1287-1294.e5. doi: 10.1016/j.fertnstert.2014.07.738. Epub 2014 Sep 11.
PubMed 25217875
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Embryo Culture and Selection by Morphokinetic Analysis; a Randomized Controlled Trial by Time-lapse System
- ClinicalTrials.gov ID
- NCT01549262
- Acronym / sponsor ID
- 1009-C-088-IR
- Conditions
- Embryo Diagnosis and Selection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Mar 2012 (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 whether the multivariable model for embryo selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison with standard incubator and an embryo selection process based exclusively in morphology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Incubator | Active comparator | Device: Observe embryo development |
| ESD Time-lapse Monitoring system | Experimental | Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673) |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female patients undergoing assisted reproduction with ICSI, first or second cycle
- 20 to 38 yers old
- BMI (18-25)
- No endometriosis,
- > 6 Metaphse II oocytes
Key exclusion criteria (3 listed)
- Hydrosalpinx
- Recurrent pregnancy loss
- Severe male factor
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 |
|---|---|---|
| Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)Observation of exact timing of embryo cleavages together with other morphology dynamics parameters. | Device | ESD Time-lapse Monitoring system |
| Observe embryo developmentObserve embryo development in the traditional manner | Device | Standard Incubator |
Primary outcome
Ongoing Pregnancy Rate
Time frame: confirmed 16-18 weeks 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 5 Aug 2014.
- Derived from this study: PubMed 28865550Insua MF, Cobo AC, Larreategui Z, Ferrando M, Serra V, Meseguer M. Obstetric and perinatal outcomes of pregnancies conceived with embryos cultured in a time-lapse monitoring system. Fertil Steril. 2017 Sep;108(3):498-504. doi: 10.1016/j.fertnstert.2017.06.031.
- Derived from this study: PubMed 25217875Rubio I, Galan A, Larreategui Z, Ayerdi F, Bellver J, Herrero J, Meseguer M. Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope. Fertil Steril. 2014 Nov;102(5):1287-1294.e5. doi: 10.1016/j.fertnstert.2014.07.738. Epub 2014 Sep 11.
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Correlation Of Clinical Outcomes After Transfer Of Good-Quality Morphology Embryos In Patients With A Favorable Prognosis And Non-Invasive Preimplantation Genetic Testing For Aneuploidy (NiPGT-A) Results
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Active, not recruiting
To Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That Develop to the Point That They Are Able to be Transferred) in IVF Cycles.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673) and Observe embryo development in people with Embryo Diagnosis and Selection, run by Instituto Valenciano de Infertilidad, IVI VALENCIA 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 7 inclusion and 3 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 5 Aug 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 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 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?
Ongoing Pregnancy Rate (time frame: confirmed 16-18 weeks after embryo transfer). 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 NCT01549262, which also lists 2 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 5 Aug 2014.