What is this study trying to find out about fertility issues?

This study is evaluating how two different oxygen concentration protocols during embryo culture affect term live birth rates and offspring health. Researchers want to understand if constant 5% oxygen or sequential 5%-2% oxygen protocols lead to better pregnancy outcomes and healthier babies. The First Affiliated Hospital with Nanjing Medical University is leading this research to improve assisted reproductive technology.

Who may be eligible for this fertility clinical trial?

Women aged between 20 and 40 years who plan to undergo their first or second IVF or ICSI cycle may be eligible. Participants must have at least four transferable embryos at the oocyte stage and no significant uterine abnormalities or uncontrolled medical conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this fertility clinical trial?

Study-related care, including the procedures and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase Not Applicable

Age: 20Years - 40Years

FEMALE

ID07050537

Comparing Constant 5% Versus Sequential 5%-2% Oxygen Levels in Embryo Culture for Women Undergoing Blastocyst Transfer Impact on Live Birth Rates and Baby Health in Assisted Reproductive Technology

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-06-01

980

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare two oxygen concentration protocolsconstant 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

Research Team

Xiang Ma

Haofeng Wang

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