Incubator StayNCT07270250
Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study
A study testing K- system incubator in people with Incubator Stay and Total Blastulation, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
IVF incubators are essential for maintaining the micro-environment required for embryo development. Incubator technology has progressed from early humidified box systems to benchtop and now time-lapse platforms, driving the development of dry incubator chambers. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incubator Stay, Total Blastulation, Blastocyst Quality
- What is being tested?
- K- system incubator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 10 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PGT-A cycles with more than at least 4 mature oocytes
- ICSI
- maternal age 18- 43 years old
- PGT-A intended cycles with trophectoderm biopsies on day 5 /6/7
- patients with more than 8 oocytes expected for ICSI
- BMI <35
- fresh and frozen ejaculated sperm
Who cannot join
- PGT-M /PGT-SR cycles
- fresh and frozen testicular sperm
- IVF insemination
- previous history of fertilization failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
JONALYN EDADES, EMBA Healthcare Management contact
United Arab Emirates1 site, 1 recruiting
- Recruiting
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, 60202
Jonalyn Edades, Research Coordinator, +97126528000, jonalyn.edades@artfertilityclinics.com
Barbara Lawrenz, Research Director, barbara.lawrenz@artfertilityclinics.com
About this study
IVF incubators are essential for maintaining the micro-environment required for embryo development. Incubator technology has progressed from early humidified box systems to benchtop and now time-lapse platforms, driving the development of dry incubator chambers. Both humidified and dry systems have specific pros and cons. Evidence to date suggests that humidified chambers may support better blastocyst development in certain "no-refresh" continuous culture conditions, but current data are limited and study designs remain weak. This study aims to compare sibling oocytes cultured in dry versus humidified chambers within a GERI time-lapse incubator under continuous culture conditions, assessing effects on viability and developmental outcomes. Findings may inform optimal incubation strategies to improve IVF success rates while supporting uninterrupted workflows and potentially improving cost-benefit efficiency in the IVF laboratory.
- Conditions
- Incubator Stay, Total Blastulation, Blastocyst Quality, Biopsy Rate, Fertilization Rate, Ploidy Rate
- Being tested
- K- system incubator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K- system incubatorDevice
Following oocyte retrieval, collected oocytes will be incubated in Global Total for Fertilization within a K-Systems incubator until the time of denudation and intracytoplasmic sperm injection (ICSI). All mature (MII) oocytes will undergo ICSI at 39-41 hours post-trigger. After insemination, sibling oocytes will be divided as equally as possible and randomly allocated into two separate Geri incubator chambers: Group 1 will be cultured in the dry chamber, and Group 2 will be cultured in the humidified chamber. A predefined randomization list will determine allocation, including cases with an uneven number of oocytes, where the additional oocyte will be assigned according to the list. Both groups will use Global TotalR (GT, CooperSurgical) single-step medium. Embryo culture will be carried out in continuous culture conditions until the blastocyst stage, following the manufacturer's GT protocol, with no Day 3 media refreshment. To minimize procedural variability, one operator will ideally
| Study group | Role | What they receive |
|---|---|---|
| Dry Chamber of Geri | Other | Not described Receives: Device: K- system incubator |
| Humidified Chamber of Geri | Other | Not described Receives: Device: K- system incubator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 5 blastulation versus total blastulation
Day 5 blastulation versus total blastulation refers to comparing the proportion of embryos that reach the blastocyst stage specifically by Day 5 against the overall number of embryos that eventually form blastocysts
Measured: Day 5 post-insemination
Blastocyst quality at time of biopsy based on modified Gardner's criteria.
Blastocyst quality at the time of biopsy will be assessed using the modified Gardner's grading system, which evaluates three key components of the blastocyst: the degree of expansion, the quality of the inner cell mass (ICM), and the quality of the trophectoderm (TE). This standardized scoring allows objective comparison of embryo morphology and developmental competence at the moment of trophectoderm biopsy.
Measured: Day 5 post-insemination
Secondary outcomes (4)
Total blastulation rates per MII and 2PN.
Total blastulation rates per MII and per 2PN refer to the proportion of inseminated mature oocytes (MII) and normally fertilized zygotes (2PN) that successfully develop into blastocysts, regardless of whether they reach this stage on Day 5 or Day 6. This measurement reflects the overall efficiency of embryo development from both the point of maturation and normal fertilization.
Measured: Day 5 post-insemination
Ploidy rate/biopsy and types of aneuploidies (segmental and mosaic)
Ploidy rate per biopsy refers to the proportion of biopsied blastocysts that return a euploid, aneuploid, mosaic or segmental result after PGT-A testing. This includes reporting the distribution of chromosomal abnormalities identified, distinguishing between full aneuploidies (whole chromosome gain or loss), segmental aneuploidies (partial chromosome changes) and mosaic patterns (mixed normal and abnormal cell lines). This outcome reflects the chromosomal competence of embryos generated under each culture condition.
Measured: Day 5 post-insemination
Blastocyst utilization rate
Blastocyst utilization rate refers to the proportion of blastocysts that are suitable for clinical use-meaning those that are either transferred, frozen for future use, or biopsied for PGT-A.
Measured: 30 days
Rate of day 5 biopsy
Rate of Day 5 biopsy refers to the proportion of blastocysts that reach the biopsy stage specifically on Day 5, relative to the total number of blastocysts biopsied.
Measured: Day 5 post-insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start10 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Incubator StayStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, leroy vas, ART Fertility Clinics LLC
- Investigators
- BARBARA LAWRENZ, PhD, Study director, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270250
- Sponsor's protocol ID
- 2504-ABU-013-LV
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon request
Publications
Bartolacci A, Borini A, Cimadomo D, Fabozzi G, Maggiulli R, Lagalla C, Pignataro D, dell'Aquila M, Parodi F, Patria G, Zaca C, Ubaldi FM, Rienzi L, Coticchio G. Humidified atmosphere in a time-lapse embryo culture system does not improve ongoing pregnancy rate: a retrospective propensity score model study derived from 496 first ICSI cycles. J Assist Reprod Genet. 2023 Jun;40(6):1429-1435. doi: 10.1007/s10815-023-02818-8. Epub 2023 May 3.
PubMed 37133689Ueno S, Ito M, Shimazaki K, Okimura T, Uchiyama K, Yabuuchi A, Kato K. Comparison of Embryo and Clinical Outcomes in Different Types of Incubator Between Two Different Embryo Culture Systems. Reprod Sci. 2021 Aug;28(8):2301-2309. doi: 10.1007/s43032-021-00504-7. Epub 2021 Mar 9.
PubMed 33751461Fawzy M, AbdelRahman MY, Zidan MH, Abdel Hafez FF, Abdelghafar H, Al-Inany H, Bedaiwy MA. Humid versus dry incubator: a prospective, randomized, controlled trial. Fertil Steril. 2017 Aug;108(2):277-283. doi: 10.1016/j.fertnstert.2017.05.036. Epub 2017 Jun 23.
PubMed 28651960Chi HJ, Park JS, Yoo CS, Kwak SJ, Son HJ, Kim SG, Sim CH, Lee KH, Koo DB. Effect of evaporation-induced osmotic changes in culture media in a dry-type incubator on clinical outcomes in in vitro fertilization-embryo transfer cycles. Clin Exp Reprod Med. 2020 Dec;47(4):284-292. doi: 10.5653/cerm.2020.03552. Epub 2020 Nov 23.
PubMed 33227188Cheredath A, Uppangala S, Asampille G, Lakshmi R V, Joseph D, Raval K, Gowda G A N, Kalthur G, Adiga SK. Duration of dry and humidified incubation of single-step embryo culture medium and oxygen tension during sham culture do not alter medium composition. F1000Res. 2022 Feb 28;11:242. doi: 10.12688/f1000research.109895.4. eCollection 2022.
PubMed 35811802Castillo CM, Harper J, Roberts SA, O'Neill HC, Johnstone ED, Brison DR. The impact of selected embryo culture conditions on ART treatment cycle outcomes: a UK national study. Hum Reprod Open. 2020 Feb 10;2020(1):hoz031. doi: 10.1093/hropen/hoz031. eCollection 2020.
PubMed 32083189
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study
- ClinicalTrials.gov ID
- NCT07270250
- Acronym / sponsor ID
- 2504-ABU-013-LV
- Conditions
- Incubator Stay, Total Blastulation, Blastocyst Quality, Biopsy Rate, Fertilization Rate, Ploidy Rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- 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.
IVF incubators are essential for maintaining the micro-environment required for embryo development. Incubator technology has progressed from early humidified box systems to benchtop and now time-lapse platforms, driving the development of dry incubator chambers. Both humidified and dry systems have specific pros and cons. Evidence to date suggests that humidified chambers may support better blastocyst development in certain "no-refresh" continuous culture conditions, but current data are limited and study designs remain weak. This study aims to compare sibling oocytes cultured in dry versus humidified chambers within a GERI time-lapse incubator under continuous culture conditions, assessing effects on viability and developmental outcomes. Findings may inform optimal incubation strategies to improve IVF success rates while supporting uninterrupted workflows and potentially improving cost-benefit efficiency in the IVF laboratory.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Chamber of Geri | Other | Device: K- system incubator |
| Humidified Chamber of Geri | Other | Device: K- system incubator |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- PGT-A cycles with more than at least 4 mature oocytes
- ICSI
- maternal age 18- 43 years old
- PGT-A intended cycles with trophectoderm biopsies on day 5 /6/7
- patients with more than 8 oocytes expected for ICSI
Key exclusion criteria (4 listed)
- PGT-M /PGT-SR cycles
- fresh and frozen testicular sperm
- IVF insemination
- previous history of fertilization failure
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 |
|---|---|---|
| K- system incubatorFollowing oocyte retrieval, collected oocytes will be incubated in Global Total for Fertilization within a K-Systems incubator until the time of denudation and intracytoplasmic sperm injection (ICSI). All mature (MII) oocytes will undergo ICSI at 39-41 hours post-trigger. After insemination, sibling oocytes will be divided as equally as possible and randomly allocated into two separate Geri incubator chambers: Group 1 will be cultured in the dry chamber, and Group 2 will be cultured in the humidified chamber. A predefined randomization list will determine allocation, including cases with an uneven number of oocytes, where the additional oocyte will be assigned according to the list. Both groups will use Global TotalR (GT, CooperSurgical) single-step medium. Embryo culture will be carried out in continuous culture conditions until the blastocyst stage, following the manufacturer's GT protocol, with no Day 3 media refreshment. To minimize procedural variability, one operator will ideally | Device | Dry Chamber of Geri, Humidified Chamber of Geri |
Primary outcome
Day 5 blastulation versus total blastulation
Time frame: Day 5 post-insemination
Day 5 blastulation versus total blastulation refers to comparing the proportion of embryos that reach the blastocyst stage specifically by Day 5 against the overall number of embryos that eventually form blastocysts
Blastocyst quality at time of biopsy based on modified Gardner's criteria.
Time frame: Day 5 post-insemination
Blastocyst quality at the time of biopsy will be assessed using the modified Gardner's grading system, which evaluates three key components of the blastocyst: the degree of expansion, the quality of the inner cell mass (ICM), and the quality of the trophectoderm (TE). This standardized scoring allows objective comparison of embryo morphology and developmental competence at the moment of trophectoderm biopsy.
4 secondary outcomes
Total blastulation rates per MII and 2PN.
Time frame: Day 5 post-insemination
Ploidy rate/biopsy and types of aneuploidies (segmental and mosaic)
Time frame: Day 5 post-insemination
Blastocyst utilization rate
Time frame: 30 days
Rate of day 5 biopsy
Time frame: Day 5 post-insemination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 37133689Bartolacci A, Borini A, Cimadomo D, Fabozzi G, Maggiulli R, Lagalla C, Pignataro D, dell'Aquila M, Parodi F, Patria G, Zaca C, Ubaldi FM, Rienzi L, Coticchio G. Humidified atmosphere in a time-lapse embryo culture system does not improve ongoing pregnancy rate: a retrospective propensity score model study derived from 496 first ICSI cycles. J Assist Reprod Genet. 2023 Jun;40(6):1429-1435. doi: 10.1007/s10815-023-02818-8. Epub 2023 May 3.
- Results publication: PubMed 33751461Ueno S, Ito M, Shimazaki K, Okimura T, Uchiyama K, Yabuuchi A, Kato K. Comparison of Embryo and Clinical Outcomes in Different Types of Incubator Between Two Different Embryo Culture Systems. Reprod Sci. 2021 Aug;28(8):2301-2309. doi: 10.1007/s43032-021-00504-7. Epub 2021 Mar 9.
- Results publication: PubMed 28651960Fawzy M, AbdelRahman MY, Zidan MH, Abdel Hafez FF, Abdelghafar H, Al-Inany H, Bedaiwy MA. Humid versus dry incubator: a prospective, randomized, controlled trial. Fertil Steril. 2017 Aug;108(2):277-283. doi: 10.1016/j.fertnstert.2017.05.036. Epub 2017 Jun 23.
- Results publication: PubMed 33227188Chi HJ, Park JS, Yoo CS, Kwak SJ, Son HJ, Kim SG, Sim CH, Lee KH, Koo DB. Effect of evaporation-induced osmotic changes in culture media in a dry-type incubator on clinical outcomes in in vitro fertilization-embryo transfer cycles. Clin Exp Reprod Med. 2020 Dec;47(4):284-292. doi: 10.5653/cerm.2020.03552. Epub 2020 Nov 23.
- Results publication: PubMed 35811802Cheredath A, Uppangala S, Asampille G, Lakshmi R V, Joseph D, Raval K, Gowda G A N, Kalthur G, Adiga SK. Duration of dry and humidified incubation of single-step embryo culture medium and oxygen tension during sham culture do not alter medium composition. F1000Res. 2022 Feb 28;11:242. doi: 10.12688/f1000research.109895.4. eCollection 2022.
- Results publication: PubMed 32083189Castillo CM, Harper J, Roberts SA, O'Neill HC, Johnstone ED, Brison DR. The impact of selected embryo culture conditions on ART treatment cycle outcomes: a UK national study. Hum Reprod Open. 2020 Feb 10;2020(1):hoz031. doi: 10.1093/hropen/hoz031. eCollection 2020.
- Individual participant dataSharing planned: No. upon request
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.
JONALYN EDADES, EMBA Healthcare Management contact
BARBARA LAWRENZ, PhD study director
ART Fertility Clinics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K- system incubator in people with Incubator Stay and Total Blastulation, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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 4 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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 United Arab Emirates. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JONALYN EDADES, EMBA Healthcare Management (+97126528000, jonalyn.edades@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 5 blastulation versus total blastulation (time frame: Day 5 post-insemination). The study lists 2 primary outcomes in all. 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 NCT07270250, which also lists 6 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 7 May 2026.