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

NCT07270250 | Not Yet Recruiting

• 1 other identifier: 2504-ABU-013-LV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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; ICSI

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Day 5 post-insemination

Secondary Outcomes (4)

• Total blastulation rates per MII and 2PN.

  Day 5 post-insemination

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

  Day 5 post-insemination

• Blastocyst utilization rate

  30 days

• Rate of day 5 biopsy

  Day 5 post-insemination

Study Arms (2)

Dry Chamber of Geri

OTHER

Device: K- system incubator

Humidified Chamber of Geri

OTHER

Device: K- system incubator

Interventions

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

Dry Chamber of Geri; Humidified Chamber of Geri

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics LLC

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

Location

Related Publications (6)

• 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.

  PMID: 37133689 RESULT

• Ueno 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.

  PMID: 33751461 RESULT

• Fawzy 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.

  PMID: 28651960 RESULT

• Chi 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.

  PMID: 33227188 RESULT

• Cheredath 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.

  PMID: 35811802 RESULT

• Castillo 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.

  PMID: 32083189 RESULT

Study Officials

• BARBARA LAWRENZ, PhD

  ART Fertility Clinics LLC

  STUDY DIRECTOR

Central Study Contacts

JONALYN EDADES, EMBA Healthcare Management

CONTACT

+97126528000; jonalyn.edades@artfertilityclinics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Embryologist

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)