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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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

Qualifiers

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.

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Constant oxygen concentration protocols in embryo culture
  • Sequential oxygen concentration protocols in embryo culture

Treatment groups

980 Participants
are divided into 2 treatment groups