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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

RecruitingNAAges 20 Years - 40 YearsFemaleThe First Affiliated Hospital with Nanjing Medica…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Constant oxygen concentration protocols in embryo culture
  • Sequential oxygen concentration protocols in embryo culture
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Where

6 sites
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Changzhou Maternal And Child Health Care Hospital
Changzhou, China
Nanjing Women and Children's Healthcare Hospital
Nanjing, China
Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
Nanjing, China
Suzhou Municipal Hospital
Suzhou, China
Northwest Women's and Children's Hospital
Xi’an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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