NCT07050537 A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology
| NCT ID | NCT07050537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Fertility Issues |
| Study Type | INTERVENTIONAL |
| Enrollment | 980 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 980 participants in total. It began in 2025-03-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07050537 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying Fertility Issues. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07050537 currently recruiting?
Yes, NCT07050537 is actively recruiting participants. Contact the research team at sxmaxiang@126.com for enrollment information.
Where is the NCT07050537 trial being conducted?
This trial is being conducted at Zhengzhou, China, Changzhou, China, Nanjing, China, Nanjing, China and 2 additional locations.
Who is sponsoring the NCT07050537 clinical trial?
NCT07050537 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 980 participants.