NCT07050537

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
980

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Mar 2025Aug 2027

Study Start

First participant enrolled

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

June 26, 2025

Last Update Submit

June 26, 2025

Conditions

Fertility IssuesBlastocyst IVFEmbryo Culture

Keywords

Blastocyst IVFFertility

Outcome Measures

Primary Outcomes (1)

  • Term live births

    Full-term healthy live birth rate for all patients

    3 years

Secondary Outcomes (5)

  • Offspring health (Peripheral blood telomere length)

    3 years

  • Clinical pregnancy rate

    3 years

  • Ectopic pregnancy rate

    3 years

  • Implantation rate

    3 years

  • Miscarriage rate

    3 years

Study Arms (2)

Constant (5%) oxygen concentration protocols in embryo culture

PLACEBO COMPARATOR

Patients randomly assigned to use constant (5%) oxygen concentration protocols in embryo culture

Procedure: Constant oxygen concentration protocols in embryo culture

Sequential (5%-2%) oxygen concentration protocols in embryo culture

EXPERIMENTAL

Patients randomly assigned to use Sequential (5%-2%) oxygen concentration protocols in embryo culture

Procedure: Sequential oxygen concentration protocols in embryo culture

Interventions

Constant oxygen concentration protocols in embryo culturePROCEDURE

Participants were randomly assigned to constant (5%) oxygen concentration group and received different blastocyst culture protocols.

Constant (5%) oxygen concentration protocols in embryo culture
Sequential oxygen concentration protocols in embryo culturePROCEDURE

Participants were randomly assigned to sequential (5%-2%) oxygen concentration group and received different blastocyst culture protocols.

Sequential (5%-2%) oxygen concentration protocols in embryo culture

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Changzhou Maternal And Child Health Care Hospital

Changzhou, Jiangsu, 213000, China

RECRUITING

Nanjing Women and Children's Healthcare Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 30576441BACKGROUND

  • 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.

    PMID: 29935641BACKGROUND

  • 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.

    PMID: 34789773BACKGROUND

  • 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.

    PMID: 33450206BACKGROUND

  • 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.

    PMID: 36599349BACKGROUND

  • 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.

    PMID: 36522605BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Xiang Ma

CONTACT

+86 18001581878sxmaxiang@126.com

Haofeng Wang

CONTACT

+86 18018387209haofengwang@stu.njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 3, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)