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

May 6, 2026 updated by: leroy vas, ART Fertility Clinics LLC
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dry Chamber of Geri
Device: K- system incubator
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
Other: Humidified Chamber of Geri
Device: K- system incubator
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 5 post-insemination
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.
Day 5 post-insemination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 5 post-insemination
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.
Day 5 post-insemination
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.
30 days
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.
Day 5 post-insemination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Study Director: Barbara Lawrenz, PhD, ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2504-ABU-013-LV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ICSI

Clinical Trials on K- system incubator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe