A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Seq… (NCT07050537) | Clinical Trial Compass
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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
China980 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range20 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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);
✕. Patients with a history of recurrent miscarriage (2 or more previous pregnancy losses, excluding biochemical pregnancies);
✕. Patients who plan to freeze whole embryos and are unable to complete a single embryo transfer within six months;
What they're measuring
1
Term live births
Timeframe: 3 years
Trial details
NCT IDNCT07050537
SponsorThe First Affiliated Hospital with Nanjing Medical University
✕. 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.