InfertilityNCT02050516
Comparison of Single vs Group Embryo Culture in Micro-well Group Culture Dish
A study testing micro-well group culture dish in people with Infertility, run by Elif Güler Ergin at 1 site in Turkey (Türkiye).
Trial summary
Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture? Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- micro-well group culture dish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2013to Jul 2014
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: female age uner 40, male age under 60 patients undergoing IVF-treatment with oocyte collection after ovarian hyperstimulation having signed the study-specific consent form patient fulfilling clinic's standard criteria for blastocyst culture minimum 5 normally fertilized oocytes at the time of fertilization check
Exclusion Criteria: use of any type of surgically retrieved sperm cells patients undergoing any kind of genetic diagnosis at any developmental stage
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eurofertil IVF Health Center
Istanbul
Hakan Ozornek, MD, +90 5325421785, hozornek@eurofertil.com
Elif Güler Ergin, MD
About this study
Official title: Randomized Controlled Comparison of Single Embryo Culture Versus Group Culture Using a Micro-well Group Culture Dish in Humans
Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture?
- Conditions
- Infertility
- Being tested
- micro-well group culture dish
- Keywords
- Blastocyst, micro-well group culture dish
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-well group culture dishOther
an embryo culture dish containing nine micro-wells in the middle.
| Study group | Role | What they receive |
|---|---|---|
| single embryo culture | Active comparator | single embryo culture in single drops inside micro-well group culture dish Receives: Other: micro-well group culture dish |
| group embryo culture | Experimental | group embryo culture in a single drop inside micro-well group culture dish Receives: Other: micro-well group culture dish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst development
Measured: 6 days
Secondary outcomes (1)
Implantation rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionJul 2014 (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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elif Güler Ergin
- Sponsor type
- University, hospital or other
- Collaborators
- Vitrolife
- Responsible party
- Sponsor-investigator, Elif Güler Ergin, Eurofertil IVF Health Center
- Investigators
- Elif Güler Ergin, MD, Principal investigator, Eurofertil IVF Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050516
- Sponsor's protocol ID
- WOW-1
- Status last verified
- Jan 2014
- First submitted
- 29 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Comparison of Single Embryo Culture Versus Group Culture Using a Micro-well Group Culture Dish in Humans
- ClinicalTrials.gov ID
- NCT02050516
- Acronym / sponsor ID
- WOW-1
- Conditions
- Infertility
- Keywords
- Blastocyst, micro-well group culture dish
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Elif Güler ErginUniversity, hospital or other
- Collaborators
- Vitrolife
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 30 Jan 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.
Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture?
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single embryo culture | Active comparator | Other: micro-well group culture dishsingle embryo culture in single drops inside micro-well group culture dish |
| group embryo culture | Experimental | Other: micro-well group culture dishgroup embryo culture in a single drop inside micro-well group culture dish |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| micro-well group culture dishan embryo culture dish containing nine micro-wells in the middle. | Other | group embryo culture, single embryo culture |
Primary outcome
Blastocyst development
Time frame: 6 days
1 secondary outcome
Implantation rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Elif Güler Ergin, MD principal investigator
Eurofertil IVF Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro-well group culture dish in people with Infertility, run by Elif Güler Ergin 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?
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 31 Jan 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Güler Ergin, MD (+90 5327882101, drelifergin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocyst development (time frame: 6 days). 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 31 Jan 2014.