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
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
980 participants
INTERVENTIONAL
2025-03-01
2027-08-31
Brief Summary
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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.
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Detailed Description
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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.
Female infertile patients who consent to blastocyst transfer will be considered for inclusion in the study. Patients will be randomly assigned to a constant (5%) or sequential (5%-2%) oxygen concentration protocols in embryo culture. This study will record live birth rates, perinatal and perinatal complications, and offspring health status of women in both groups of embryo culture regimens to assess the effects of different embryo culture regimens on term live birth rates and offspring health.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Constant (5%) oxygen concentration protocols in embryo culture
Patients randomly assigned to use constant (5%) oxygen concentration protocols in embryo culture
Constant oxygen concentration protocols in embryo culture
Participants were randomly assigned to constant (5%) oxygen concentration group and received different blastocyst culture protocols.
Sequential (5%-2%) oxygen concentration protocols in embryo culture
Patients randomly assigned to use Sequential (5%-2%) oxygen concentration protocols in embryo culture
Sequential oxygen concentration protocols in embryo culture
Participants were randomly assigned to sequential (5%-2%) oxygen concentration group and received different blastocyst culture protocols.
Interventions
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Constant oxygen concentration protocols in embryo culture
Participants were randomly assigned to constant (5%) oxygen concentration group and received different blastocyst culture protocols.
Sequential oxygen concentration protocols in embryo culture
Participants were randomly assigned to sequential (5%-2%) oxygen concentration group and received different blastocyst culture protocols.
Eligibility Criteria
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Inclusion Criteria
2. Proposed 1st or 2nd cycle of IVF or ICSI fertilization;
3. ≥ 4 transferable embryos at oocyte stage.
Exclusion Criteria
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.
20 Years
40 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Locations
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The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Changzhou Maternal And Child Health Care Hospital
Changzhou, Jiangsu, China
Nanjing Women and Children's Healthcare Hospital
Nanjing, Jiangsu, China
Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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De Munck N, Janssens R, Segers I, Tournaye H, Van de Velde H, Verheyen G. Influence of ultra-low oxygen (2%) tension on in-vitro human embryo development. Hum Reprod. 2019 Feb 1;34(2):228-234. doi: 10.1093/humrep/dey370.
Kaser DJ, Bogale B, Sarda V, Farland LV, Williams PL, Racowsky C. Randomized controlled trial of low (5%) versus ultralow (2%) oxygen for extended culture using bipronucleate and tripronucleate human preimplantation embryos. Fertil Steril. 2018 Jun;109(6):1030-1037.e2. doi: 10.1016/j.fertnstert.2018.02.119.
Brouillet S, Baron C, Barry F, Andreeva A, Haouzi D, Gala A, Ferrieres-Hoa A, Loup V, Anahory T, Ranisavljevic N, Gaspari L, Hamamah S. Biphasic (5-2%) oxygen concentration strategy significantly improves the usable blastocyst and cumulative live birth rates in in vitro fertilization. Sci Rep. 2021 Nov 17;11(1):22461. doi: 10.1038/s41598-021-01782-6.
Chakravarti D, LaBella KA, DePinho RA. Telomeres: history, health, and hallmarks of aging. Cell. 2021 Jan 21;184(2):306-322. doi: 10.1016/j.cell.2020.12.028. Epub 2021 Jan 14.
Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. Hallmarks of aging: An expanding universe. Cell. 2023 Jan 19;186(2):243-278. doi: 10.1016/j.cell.2022.11.001. Epub 2023 Jan 3.
Wang C, Gu Y, Zhou J, Zang J, Ling X, Li H, Hu L, Xu B, Zhang B, Qin N, Lv H, Duan W, Jiang Y, He Y, Jiang T, Chen C, Han X, Zhou K, Xu B, Liu X, Tao S, Jiang Y, Du J, Dai J, Diao F, Lu C, Guo X, Huo R, Liu J, Lin Y, Xia Y, Jin G, Ma H, Shen H, Hu Z. Leukocyte telomere length in children born following blastocyst-stage embryo transfer. Nat Med. 2022 Dec;28(12):2646-2653. doi: 10.1038/s41591-022-02108-3. Epub 2022 Dec 15.
Other Identifiers
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RCT-ECP
Identifier Type: -
Identifier Source: org_study_id
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