About this trial
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
This trial does not accept healthy volunteersQualifiers
Female: age ≥20 and ≤40 years, male: age ≥20 and ≤50 years;
Proposed 1st or 2nd cycle of IVF or ICSI fertilization;
≥ 4 transferable embryos at oocyte stage.
Disqualifiers
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;
Patients who are proposed to undergo IVM;
Patients who are proposed to undergo PGD/ PGS;
Patients with untreated severe hydrosalpinx (confirmed by ultrasound or HSG);
Trial design
Parallel
Treatments tested in this trial
Constant oxygen concentration protocols in embryo culture
Procedure/SurgeryParticipants were randomly assigned to constant (5%) oxygen concentration group and received different blastocyst culture protocols.
Sequential oxygen concentration protocols in embryo culture
Procedure/SurgeryParticipants were randomly assigned to sequential (5%-2%) oxygen concentration group and received different blastocyst culture protocols.
Treatment groups
Trial outcomes
Primary outcomes
Term live births
Full-term healthy live birth rate for all patients
Secondary outcomes
Offspring health (Peripheral blood telomere length)
Peripheral blood telomere length in all live-born offspring
Clinical pregnancy rate
Clinical pregnancy rate for all transfer cycles
Ectopic pregnancy rate
Ectopic pregnancy rate for all transfer cycles
Implantation rate
Implantation rate per transfer cycle
Sponsors and contacts
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