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A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-07-03
980
Participants Needed
5
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate whether there were significant differences in the effects of constant (5%) versus sequential (5%-2%) oxygen concentration protocols in embryo culture on term live birth rates. This study will be conducted in five centers including the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical Universit. 980 women who wish to undergo blastocyst transplantation will be included in the study. The study data will be analyzed statistically.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Female participants aged 20 to 40 years, male partners aged 20 to 50 years
- Planned first or second IVF or ICSI fertilization cycle
- At least 4 transferable embryos at the oocyte stage
You will not qualify if you...
- Abnormal uterine cavity morphology confirmed by imaging, including uterine malformations, submucosal fibroids, or adhesions
- Planned to undergo in vitro maturation (IVM)
- Planned to undergo preimplantation genetic diagnosis or screening (PGD/PGS)
- Untreated severe hydrosalpinx confirmed by ultrasound or hysterosalpingography
- 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, previous venous thrombosis, pulmonary embolism, cerebrovascular events, history or suspicion of malignant tumors, or undiagnosed abnormal uterine bleeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
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2
Changzhou Maternal And Child Health Care Hospital
Changzhou, Jiangsu, China, 213000
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3
Nanjing Women and Children's Healthcare Hospital
Nanjing, Jiangsu, China, 210000
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4
Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
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5
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
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Research Team
X
Xiang Ma
CONTACT
H
Haofeng Wang
CONTACT
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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