Status:

RECRUITING

A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology

Lead Sponsor:

The First Affiliated Hospital with Nanjing Medical University

Conditions:

Fertility Issues

Blastocyst IVF

Eligibility:

FEMALE

20-40 years

Phase:

NA

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 ...

Detailed Description

While blastocyst transfer has been shown to improve live birth rates, concerns exist regarding potential telomere shortening in offspring, which is associated with premature aging and various health i...

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.

Key Trial Info

Start Date :

March 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2027

Estimated Enrollment :

980 Patients enrolled

Trial Details

Trial ID

NCT07050537

Start Date

March 1 2025

End Date

August 31 2027

Last Update

July 3 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450000

2

Changzhou Maternal And Child Health Care Hospital

Changzhou, Jiangsu, China, 213000

3

Nanjing Women and Children's Healthcare Hospital

Nanjing, Jiangsu, China, 210000

4

Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China