In-vitro FertilizationNCT01507883
Time-lapse Evaluation of Human Embryo Development in Single Versus Sequential Culture Media - a Sibling Oocyte Study
An observational study of In-vitro Fertilization, run by Bahceci Health Group at 1 site in Turkey (Türkiye).
Trial summary
Current human IVF technology employs two strategies with respective culture media for embryo development; 'let the embryo choose' (utilizes single step media) and 'back-to-nature' (utilizes sequential media). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- In-vitro Fertilization
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2011to Jan 2012
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult
Study population: Women who had undergone infertility treatment and oocytes subjected to ICSI
Who may be able to join
- Cycles which have gone through egg retrieval procedure between March to November 2011 were included into the study.There was no restriction on the number of previous trials and/or sperm source.
Who cannot join
- The maximum number of retrieved oocytes was restricted to 12 and the minimum to 2, as the former was the capacity of one dish (EmbryoSlide™) in which oocytes/embryos could be placed and the latter was the minimum number to be able to make a comparison between groups. Women who were older than 40 years of age were excluded in order to minimize the impact of increased risk of aneuploidy on the results.
- Cycles in which oocytes/embryos have been subjected to biopsy were also excluded due to the potential risk of delayed embryo development in such cases (Kirkegaard et al., 2011).
- Furthermore, cycles in which diagnosis of infertility was endometrial factor were not included since such aetiology could negatively affect implantation despite good embryo development.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bahceci Fulya IVF Clinic
Istanbul
Nadir Ciray, MD., PhD, +90 2123103100
Mustafa Bahceci, MD
About this study
Current human IVF technology employs two strategies with respective culture media for embryo development; 'let the embryo choose' (utilizes single step media) and 'back-to-nature' (utilizes sequential media). To our knowledge, there is not any sibling oocyte study to evaluate potential advantages/disadvantages of these strategies on one another.
Read the detailed description
Maintaining optimal embryo development during in vitro culture is a key element in assisted reproduction treatments. Whether the concept of mimicking in vivo environment is a 'must' in order not to compromise outcome is a matter of debate since 'let the embryo choose' strategy has been shown to perform at least as good as the 'back to nature' in several studies.'Let the embryo choose" approach utilizes a milieu with relatively constant concentration of ingredients (single culture system) as compared to the latter, in which demands of the embryos are supported according to their passage from the Fallopian tubes to the uterus in a sequential culture media. Basic differences between these ingredients are; presence of (1) glucose instead of pyruvate, and (2) essential aminoacids in early embryo stages (until day 3) in single step media, and (3) presence of EDTA in sequential media.
Vast majority of these results were obtained from studies where patients have been randomized into groups instead of employing a sibling (oocyte/embryo) model which could have enabled each patient to serve as her own control. In fact, it has been claimed that introducing a sibling oocyte study design could give a methodological problem at the time of fertilization since different type of culture media vary in osmolarity. Likewise the only study that employed a sibling oocyte model utilized two different media (home-made versus G1.2/G1.2) although the osmolarity of the former had been adjusted to 280-285 mOsm). This study reported no significant differences in day3/5 embryo development as well as pregnancy/implantation rates between groups.
Subsequent studies, however, favoured single step media, as they found higher proportion of compacted embryos to zygotes at day3, morula at 4, a higher blastocyst yield, an overall higher utilization rate after day5 and an improved implantation rate when compared to sequential media. Yet, besides potential variation of gamete qualities between patients allocated to groups (as described above), differences in static observation times of embryos between laboratories could have affected the results in these studies. Current introduction of time-lapse equipment into human assisted reproduction technology enabled a more distinct definition of embryo development and it is now possible to quantify pace of embryo cleavage in various media. Such a definition is also useful to determine the predictive value of embryo development in pre-defined time points will be applicable to all embryology laboratories using various culture systems.
- Conditions
- In-vitro Fertilization
- Keywords
- Supervision, embryos, Resulting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| human oocytes/embryos | Sibling oocytes cultured in single or sequential media until day6 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionJan 2012 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahceci Health Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. NADIR CIRAY, Bahceci Health Group
- Investigators
- Nadir H Ciray, MD., PhD, Principal investigator, Bahceci Health GroupTuran Aksoy, BS, Study chair, Bahceci Health GroupMustafa Bahceci, MD, Study director, Bahceci Health GroupCihan Goktas, BS, Study chair, Bahceci Health GroupBirgen Ozturk, BS, Study chair, Bahceci Health Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507883
- Sponsor's protocol ID
- BHC1
- Status last verified
- Jan 2012
- First submitted
- 9 Jan 2012
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-lapse Evaluation of Human Embryo Development in Single Versus Sequential Culture Media - a Sibling Oocyte Study
- ClinicalTrials.gov ID
- NCT01507883
- Acronym / sponsor ID
- BHC1
- Conditions
- In-vitro Fertilization
- Keywords
- Supervision, embryos, Resulting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bahceci Health GroupUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (estimated)
- First posted
- 11 Jan 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.
Current human IVF technology employs two strategies with respective culture media for embryo development; 'let the embryo choose' (utilizes single step media) and 'back-to-nature' (utilizes sequential media). To our knowledge, there is not any sibling oocyte study to evaluate potential advantages/disadvantages of these strategies on one another.
Detailed description
Maintaining optimal embryo development during in vitro culture is a key element in assisted reproduction treatments. Whether the concept of mimicking in vivo environment is a 'must' in order not to compromise outcome is a matter of debate since 'let the embryo choose' strategy has been shown to perform at least as good as the 'back to nature' in several studies.'Let the embryo choose" approach utilizes a milieu with relatively constant concentration of ingredients (single culture system) as compared to the latter, in which demands of the embryos are supported according to their passage from the Fallopian tubes to the uterus in a sequential culture media. Basic differences between these ingredients are; presence of (1) glucose instead of pyruvate, and (2) essential aminoacids in early embryo stages (until day 3) in single step media, and (3) presence of EDTA in sequential media.
Vast majority of these results were obtained from studies where patients have been randomized into groups instead of employing a sibling (oocyte/embryo) model which could have enabled each patient to serve as her own control. In fact, it has been claimed that introducing a sibling oocyte study design could give a methodological problem at the time of fertilization since different type of culture media vary in osmolarity. Likewise the only study that employed a sibling oocyte model utilized two different media (home-made versus G1.2/G1.2) although the osmolarity of the former had been adjusted to 280-285 mOsm). This study reported no significant differences in day3/5 embryo development as well as pregnancy/implantation rates between groups.
Subsequent studies, however, favoured single step media, as they found higher proportion of compacted embryos to zygotes at day3, morula at 4, a higher blastocyst yield, an overall higher utilization rate after day5 and an improved implantation rate when compared to sequential media. Yet, besides potential variation of gamete qualities between patients allocated to groups (as described above), differences in static observation times of embryos between laboratories could have affected the results in these studies. Current introduction of time-lapse equipment into human assisted reproduction technology enabled a more distinct definition of embryo development and it is now possible to quantify pace of embryo cleavage in various media. Such a definition is also useful to determine the predictive value of embryo development in pre-defined time points will be applicable to all embryology laboratories using various culture systems.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| human oocytes/embryos | – | –Sibling oocytes cultured in single or sequential media until day6 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who had undergone infertility treatment and oocytes subjected to ICSI
Key inclusion criteria (1 listed)
- Cycles which have gone through egg retrieval procedure between March to November 2011 were included into the study.There was no restriction on the number of previous trials and/or sperm source.
Key exclusion criteria (3 listed)
- The maximum number of retrieved oocytes was restricted to 12 and the minimum to 2, as the former was the capacity of one dish (EmbryoSlide™) in which oocytes/embryos could be placed and the latter was the minimum number to be able to make a comparison between groups. Women who were older than 40 years of age were excluded in order to minimize the impact of increased risk of aneuploidy on the results.
- Cycles in which oocytes/embryos have been subjected to biopsy were also excluded due to the potential risk of delayed embryo development in such cases (Kirkegaard et al., 2011).
- Furthermore, cycles in which diagnosis of infertility was endometrial factor were not included since such aetiology could negatively affect implantation despite good embryo development.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
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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.
Nadir H Ciray, MD., PhD principal investigator
Bahceci Health Group
Turan Aksoy, BS study chair
Bahceci Health Group
Mustafa Bahceci, MD study director
Bahceci Health Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-vitro Fertilization, run by Bahceci Health Group 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 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 2012. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 11 Jan 2012.