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

NCT ID: NCT07270250

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dry Chamber of Geri

Group Type OTHER

K- system incubator

Intervention Type 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

Humidified Chamber of Geri

Group Type OTHER

K- system incubator

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ART Fertility Clinics LLC

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

leroy vas

Embryologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

BARBARA LAWRENZ, PhD

Role: STUDY_DIRECTOR

ART Fertility Clinics LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Arab Emirates

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

JONALYN EDADES, EMBA Healthcare Management

Role: CONTACT

+97126528000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jonalyn Edades, Research Coordinator

Role: primary

+97126528000

Barbara Lawrenz, Research Director

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 37133689 (View on PubMed)

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.

Reference Type RESULT
PMID: 33751461 (View on PubMed)

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.

Reference Type RESULT
PMID: 28651960 (View on PubMed)

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.

Reference Type RESULT
PMID: 33227188 (View on PubMed)

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.

Reference Type RESULT
PMID: 35811802 (View on PubMed)

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.

Reference Type RESULT
PMID: 32083189 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2504-ABU-013-LV

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.