InfertilityNCT01773603
Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer
A study testing Embryoscope in people with Infertility, run by Dr. Murat Çetinkaya at 1 site in Turkey (Türkiye).
Trial summary
Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Embryoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2011to 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients in their first or second ART treatment cycle
- no recurrent spontaneous abortions
- age<35 years
- BMI<28 kg/m2
- ≥8 oocytes retrieved
Who cannot join
- severe endometriosis
- polycystic ovary syndrome
- hydrosalpynx
- uterine pathology
- severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)
- very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)
Trial locations and contacts
1 site in 1 country.
About this study
Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion.
This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.
- Conditions
- Infertility
- Being tested
- Embryoscope
- Keywords
- Time-lapse, morphokinetics, blastocyst transfer, eSET
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbryoscopeDevice
Also called Time-lapse monitoring of human embryos in Embryoscope
Five-day embryo culture in embryoscope which is an incubator with a built-in camera
| Study group | Role | What they receive |
|---|---|---|
| Conventional incubation | No intervention | Five-day embryo culture in conventional incubators |
| Embryoscope | Active comparator | Five-day embryo culture in embryoscope which is an incubator with a built-in camera Receives: Device: Embryoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst formation rate
Measured: 5th day of embryonic development
Secondary outcomes (1)
Clinical pregnancy rate
Clinical pregnancy was defined as the presence of a gestational sac detected on ultrasound 3 weeks after the first βhCG test, which was performed 14 days after oocyte retrieval.
Measured: 7th week of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJul 2012
Why it stopped: No statistical difference observed for outcomes.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Murat Çetinkaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Murat Çetinkaya, Memorial Sisli Hospital, Istanbul
- Investigators
- Semra Kahraman, MD, Prof, Study director, Sisli Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773603
- Sponsor's protocol ID
- MC0405
- Other IDs
- IMH2013-1
- Status last verified
- Jan 2013
- First submitted
- 18 Jan 2013
- 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
- Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer
- ClinicalTrials.gov ID
- NCT01773603
- Acronym / sponsor ID
- MC0405
- Conditions
- Infertility
- Keywords
- Time-lapse, morphokinetics, blastocyst transfer, eSET
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No statistical difference observed for outcomes.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dr. Murat ÇetinkayaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Jan 2013 (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.
Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion.
This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional incubation | No intervention | –Five-day embryo culture in conventional incubators |
| Embryoscope | Active comparator | Device: EmbryoscopeFive-day embryo culture in embryoscope which is an incubator with a built-in camera |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients in their first or second ART treatment cycle
- no recurrent spontaneous abortions
- age<35 years
- BMI<28 kg/m2
- ≥8 oocytes retrieved
Key exclusion criteria (6 listed)
- severe endometriosis
- polycystic ovary syndrome
- hydrosalpynx
- uterine pathology
- severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)
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 |
|---|---|---|
| EmbryoscopeAlso: Time-lapse monitoring of human embryos in EmbryoscopeFive-day embryo culture in embryoscope which is an incubator with a built-in camera | Device | Embryoscope |
Primary outcome
Blastocyst formation rate
Time frame: 5th day of embryonic development
1 secondary outcome
Clinical pregnancy rate
Time frame: 7th week of pregnancy
Results and safety
The study was stopped early (reason given: No statistical difference observed for outcomes.). Results are not available in the source record.
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.
Semra Kahraman, MD, Prof study director
Sisli Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embryoscope in people with Infertility, run by Dr. Murat Çetinkaya at 1 site in Turkey (Türkiye).
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 6 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 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 1 site in Turkey (Türkiye). 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: No statistical difference observed for outcomes.). 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?
Blastocyst formation rate (time frame: 5th day of embryonic development). 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.