Constant 5% versus sequential 5% to 2% oxygen for embryo culture in IVF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a multicenter, randomized controlled design, about 980 women planning blastocyst transfer will be assigned to embryo culture under either a constant 5% oxygen environment or a sequential 5%→2% oxygen protocol. The trial will be conducted at five Chinese reproductive centers using standard IVF/ICSI procedures with random allocation at the embryo culture stage. Primary outcome is term live birth rate, and secondary outcomes include perinatal complications and offspring telomere length and health measures. All data will be analyzed statistically to compare clinical and offspring outcomes between the two oxygen regimens.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Third Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Changzhou Maternal And Child Health Care Hospital
  Changzhou, Jiangsu, China Recruiting
• Nanjing Women and Children's Healthcare Hospital
  Nanjing, Jiangsu, China Recruiting
• Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• Suzhou Municipal Hospital
  Suzhou, Jiangsu, China Recruiting
• Northwest Women's and Children's Hospital
  Xi’an, Shanxi, China Recruiting

Study contacts

• Study coordinator: Xiang Ma
• Email: sxmaxiang@126.com
• Phone: +86 18001581878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.