In Vitro FertilizationNCT02222831
Optimizing IVF Treatment - the Impact of Time-lapse Culture and Preimplantation Factor (PIF) on Embryo Development.
A study testing Day 0 denudation and time lapse culture on IVF-oocytes. in people with In Vitro Fertilization and Assisted Reproductive Techniques, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
Trial summary
The aims of this study are to evaluate: 1. the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on fertilisation rates and embryo quality in standard IVF. 2. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- In Vitro Fertilization, Assisted Reproductive Techniques
- What is being tested?
- Day 0 denudation and time lapse culture on IVF-oocytes.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Dec 2022
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Standard IVF treatment
- Body mass Index (BMI) between 18 and 30
- couples in which the male partner has normal sperm concentration and motility according to the World Health Organization (WHO, 2010)
Who cannot join
- Patients with less than four oocytes
Trial locations and contacts
1 site in 1 country.
About this study
The aims of this study are to evaluate:
- the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on fertilisation rates and embryo quality in standard IVF.
- the association between PIF status in embryo culture medium and embryo quality assessed by standard subjective parameters and morphokinetic development.
- Being tested
- Day 0 denudation and time lapse culture on IVF-oocytes.
- Keywords
- IVF, Embryo Quality, Time Lapse Culture, Preimplantation factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day 0 denudation and time lapse culture on IVF-oocytes.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Day 0 - Study arm | Experimental | Day 0 denudation and time lapse culture on IVF-oocytes.:
After insemination the oocytes will subsequently be denuded and cultured in the EmbryoScope (day 0).
The embryo culture media will be collected at day 2-5. Receives: Procedure: Day 0 denudation and time lapse culture on IVF-oocytes. |
| Day 1 - control arm | No intervention | After insemination oocytes in the control group will be incubated in a standard incubator overnight. On day 1 the oocytes in the will be denuded and further cultured in the EmbryoScope. The embryo culture media will be collected at day 2-5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo Quality
Measured: Day 0-5 after oocyte pick-up
Secondary outcomes (1)
Fertilisation rate
Measured: Day 1 after oocyte pick-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2016
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Viborg, Skive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betina Boel Povlsen, MSc, Regionshospitalet Viborg, Skive
- Investigators
- Betina B Povlsen, MSc, Principal investigator, The Fertility Clinic, Skive Regional Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222831
- Sponsor's protocol ID
- Skive-2014-BBP
- Status last verified
- May 2022
- First submitted
- 20 Aug 2014
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing IVF Treatment - the Impact of Time-lapse Culture and Preimplantation Factor (PIF) on Embryo Development.
- ClinicalTrials.gov ID
- NCT02222831
- Acronym / sponsor ID
- Skive-2014-BBP
- Keywords
- IVF, Embryo Quality, Time Lapse Culture, Preimplantation factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Regionshospitalet Viborg, SkiveUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Aug 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.
The aims of this study are to evaluate:
- the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on fertilisation rates and embryo quality in standard IVF.
- the association between PIF status in embryo culture medium and embryo quality assessed by standard subjective parameters and morphokinetic development.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 0 - Study arm | Experimental | Procedure: Day 0 denudation and time lapse culture on IVF-oocytes.Day 0 denudation and time lapse culture on IVF-oocytes.: After insemination the oocytes will subsequently be denuded and cultured in the EmbryoScope (day 0). The embryo culture media will be collected at day 2-5. |
| Day 1 - control arm | No intervention | –After insemination oocytes in the control group will be incubated in a standard incubator overnight. On day 1 the oocytes in the will be denuded and further cultured in the EmbryoScope. The embryo culture media will be collected at day 2-5. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Standard IVF treatment
- Body mass Index (BMI) between 18 and 30
- couples in which the male partner has normal sperm concentration and motility according to the World Health Organization (WHO, 2010)
Key exclusion criteria (1 listed)
- Patients with less than four oocytes
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 |
|---|---|---|
| Day 0 denudation and time lapse culture on IVF-oocytes. | Procedure or surgery | Day 0 - Study arm |
Primary outcome
Embryo Quality
Time frame: Day 0-5 after oocyte pick-up
1 secondary outcome
Fertilisation rate
Time frame: Day 1 after oocyte pick-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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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.
Betina B Povlsen, MSc principal investigator
The Fertility Clinic, Skive Regional Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day 0 denudation and time lapse culture on IVF-oocytes. in people with In Vitro Fertilization and Assisted Reproductive Techniques, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
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 3 inclusion and 1 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 17 May 2022. 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 Denmark. 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?
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?
Embryo Quality (time frame: Day 0-5 after oocyte pick-up). 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 17 May 2022.