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