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Clinical Trials in China / NCT07050537
Recruiting Not applicable

A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology

NCT07050537 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (6)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT07050537 on ClinicalTrials.gov ↗ ← All trials in China