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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Constant oxygen concentration protocols in embryo culture

    Procedure/Surgery

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

  • Sequential oxygen concentration protocols in embryo culture

    Procedure/Surgery

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

Treatment groups

980 Participants
are divided into 2 treatment groups
Group A: Constant (5%) oxygen concentration protocols in embryo culturePlacebo comparator 1 intervention
Group B: Sequential (5%-2%) oxygen concentration protocols in embryo cultureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Term live births

Full-term healthy live birth rate for all patients

Time frame
3 years

Secondary outcomes

1

Offspring health (Peripheral blood telomere length)

Peripheral blood telomere length in all live-born offspring

Time frame
3 years
2

Clinical pregnancy rate

Clinical pregnancy rate for all transfer cycles

Time frame
3 years
3

Ectopic pregnancy rate

Ectopic pregnancy rate for all transfer cycles

Time frame
3 years
4

Implantation rate

Implantation rate per transfer cycle

Time frame
3 years

Other outcomes

Sponsors and contacts

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