The First Affiliated Hospital with Nanjing Medical University
Phase
Not applicable
Started
2025-03-01
Last updated
2026-06-01
Condition(s) studied
Fertility IssuesBlastocyst IVFEmbryo Culture
Investigational drug(s) / intervention(s)
Constant oxygen concentration protocols in embryo cultureSequential oxygen concentration protocols in embryo culture
Constant oxygen concentration protocols in embryo culture: Participants were randomly assigned to constant (5%) oxygen concentration group and received different blastocyst culture protocols.
Sequential oxygen concentration protocols in embryo culture: Participants were randomly assigned to sequential (5%-2%) oxygen concentration group and received different blastocyst culture protocols.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
20 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria:
1. Female: age ≥20 and ≤40 years, male: age ≥20 and ≤50 years;
2. Proposed 1st or 2nd cycle of IVF or ICSI fertilization;
3. ≥ 4 transferable embryos at oocyte stage.
Exclusion Criteria:
1. Diagnosis of abnormal uterine cavity morphology (confirmed by 3D ultrasound or hysteroscopy), including uterine malformations (mediastinal uterus, unicornuate uterus, bicornuate uterus), submucosal uterine fibroids, or uterine adhesions;
2. Patients who are proposed to undergo IVM;
3. Patients who are proposed to undergo PGD/ PGS;
4. Patients with untreated severe hydrosalpinx (confirmed by ultrasound or HSG);
5. Patients with a history of recurrent miscarriage (2 or more previous pregnancy losses, excluding biochemical pregnancies);
6. Patients who plan to freeze whole embryos and are unable to complete a single embryo transfer within six months;
7. Patients with contraindications to assisted reproductive technology and pregnancy, or suffering from diseases that have a definite effect on pregnancy: including uncontrolled hypertension, heart disease with definite symptoms, uncontrolled diabetes, undefined diagnosis of liver or kidney disease or liver or kidney insufficiency, severe anemia, history of previous venous thrombosis, pulmonary embolism or cerebrovascular events, history of malignant tumors, suspected malignant tumors, and undiagnosed abnormal uterine bleeding.
Primary outcome measure(s)
Term live births — 3 years Full-term healthy live birth rate for all patients
Trial sites (6)
Facility
City
Region
Status
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Recruiting
Changzhou Maternal And Child Health Care Hospital
Changzhou
Jiangsu
Recruiting
Nanjing Women and Children's Healthcare Hospital
Nanjing
Jiangsu
Recruiting
Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
Nanjing
Jiangsu
Recruiting
Suzhou Municipal Hospital
Suzhou
Jiangsu
Recruiting
Northwest Women's and Children's Hospital
Xi’an
Shanxi
Recruiting
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.