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NCT Number: NCT07270250

Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte 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.

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Key information

Conditions

Incubator Stay Biopsy Rate Blastocyst Quality Fertilization Rate ICSI Ploidy Rate Total Blastulation

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

Location status: Recruiting

Location contact

Barbara Lawrenz, Research Director

CONTACT

[email protected]

Jonalyn Edades, Research Coordinator

CONTACT

[email protected]

+97126528000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • PGT-M /PGT-SR cycles
  • fresh and frozen testicular sperm
  • IVF insemination
  • previous history of fertilization failure

Treatment and study plan

K- system incubator

Device

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Total blastulation rates per MII and 2PN.

    Time frame: Day 5 post-insemination

    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.

  2. Ploidy rate/biopsy and types of aneuploidies (segmental and mosaic)

    Time frame: Day 5 post-insemination

    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.

  3. Blastocyst utilization rate

    Time frame: 30 days

    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.

  4. Rate of day 5 biopsy

    Time frame: Day 5 post-insemination

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

JONALYN EDADES, EMBA Healthcare Management

CONTACT

[email protected]

+97126528000

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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