Influence of ultra-low oxygen (2%) tension on in-vitro human embryo development.
N De Munck, R Janssens, I Segers...
https://pubmed.ncbi.nlm.nih.gov/30576441Actively Recruiting
Phase Not Applicable
Age: 20Years - 40Years
FEMALE
ID07050537
A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology Evaluating Term Live Birth and Offspring Health Outcomes
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-06-01
980
Participants Needed
6
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two oxygen concentration protocols—constant 5% versus sequential 5%-2%—used during embryo culture in assisted reproductive technology. The study focuses on women undergoing blastocyst transplantation to evaluate differences in term live birth rates and offspring health, including potential effects on telomere length, which is linked to aging and health outcomes. The trial is conducted across five centers, including the Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University. Participants are randomly assigned to one of two groups: one receives embryo culture under a constant 5% oxygen concentration, and the other under a sequential protocol reducing from 5% to 2%. Both groups follow their respective blastocyst culture protocols during in vitro fertilization or intracytoplasmic sperm injection cycles. The study monitors outcomes related to live births and health status of offspring associated with each oxygen protocol. Women enrolled in the trial will be followed for three years, during which live birth rates, clinical pregnancy rates, implantation rates, miscarriage rates, and ectopic pregnancy rates will be recorded. Researchers will also assess offspring health by measuring peripheral blood telomere length. Evaluations include monitoring pregnancy outcomes and any perinatal complications. Data will be statistically analyzed to determine the effects of oxygen concentration protocols on reproductive success and offspring well-being.
CONDITIONS
Brief Title
A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology
Who Can Participate
Age: 20Years - 40Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female aged 20 to 40 years, male aged 20 to 50 years
- Planning first or second cycle of IVF or ICSI fertilization
- Having at least 4 transferable embryos at the oocyte stage
You will not qualify if you...
- Abnormal uterine cavity morphology or uterine malformations confirmed by 3D ultrasound or hysteroscopy
- Proposed use of in vitro maturation (IVM)
- Planned preimplantation genetic diagnosis (PGD) or screening (PGS)
- Untreated severe hydrosalpinx confirmed by ultrasound or HSG
- History of recurrent miscarriage (2 or more pregnancy losses excluding biochemical pregnancies)
- Plan to freeze all embryos and unable to complete single embryo transfer within six months
- Contraindications to assisted reproductive technology or pregnancy, including uncontrolled hypertension, symptomatic heart disease, uncontrolled diabetes, liver or kidney disease or insufficiency, severe anemia, history of venous thrombosis, pulmonary embolism, cerebrovascular events, malignant tumors, suspected tumors, or unexplained abnormal uterine bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to embryo transfer and pregnancy confirmation period
Participants receive either constant (5%) or sequential (5%-2%) oxygen concentration protocols during embryo culture as part of assisted reproductive technology.
Visits aligned with embryo culture and transfer procedures
Follow-up
Duration - Up to 3 years
Participants and offspring are followed to assess term live birth rates, offspring health outcomes, and pregnancy outcomes.
Periodic visits for health assessments over 3 years
Trial Site Locations
Total: 6 locations
1
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Actively Recruiting
2
Changzhou Maternal And Child Health Care Hospital
Changzhou, Jiangsu, China, 213000
Actively Recruiting
3
Nanjing Women and Children's Healthcare Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
4
Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
5
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Actively Recruiting
6
Northwest Women's and Children's Hospital
Xi’an, Shanxi, China, 710000
Actively Recruiting
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Research Team
X
Xiang Ma
H
Haofeng Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Randomized controlled trial of low (5%) versus ultralow (2%) oxygen for extended culture using bipronucleate and tripronucleate human preimplantation embryos.
Daniel J Kaser, Berhan Bogale, Vishnudas Sarda...
https://pubmed.ncbi.nlm.nih.gov/29935641Biphasic (5-2%) oxygen concentration strategy significantly improves the usable blastocyst and cumulative live birth rates in in vitro fertilization.
Sophie Brouillet, Chloé Baron, Fatima Barry...
https://pubmed.ncbi.nlm.nih.gov/34789773Telomeres: history, health, and hallmarks of aging.
Deepavali Chakravarti, Kyle A LaBella, Ronald A DePinho
https://pubmed.ncbi.nlm.nih.gov/33450206Hallmarks of aging: An expanding universe.
Carlos López-Otín, Maria A Blasco, Linda Partridge...
https://pubmed.ncbi.nlm.nih.gov/36599349Leukocyte telomere length in children born following blastocyst-stage embryo transfer.
Cheng Wang, Yayun Gu, Jun Zhou...
https://pubmed.ncbi.nlm.nih.gov/36522605