Influence of Manipulation of Oocytes and Embryos in Low Oxygen Tension on Assisted Reproduction Technology Outcome

May 21, 2021 updated by: The University of Hong Kong-Shenzhen Hospital

Nowadays, most assisted reproduction laboratories attempt to maintain as much as possible ex vivo culture conditions comparable to those in vivo. Various culturing condition such as temperature and pH parameters have been adjusted according to in vivo values in order to improve in-vitro fertilization (IVF) outcomes. Embryos of most mammals, including that of humans, are not exposed to oxygen concentration higher than 8%. Thus, embryos and gametes should be kept in a low oxygen environment during manipulation in assisted reproduction treatment.

Culturing embryos in low oxygen concentrations is now a general practice in IVF laboratories. However, there are still laboratory procedures when the oocytes/embryos are exposed to atmospheric oxygen. In most laboratories, oocytes retrieval is performed under atmospheric oxygen concentration. Oocyte is very sensitive to environmental changes, for instance, transient cooling to room temperature can cause irreversible disruption of the meiotic spindle in human oocytes and oocyte in vitro maturation can lead to the decline of energy metabolism in human oocytes. Whether oocyte exposed to atmospheric oxygen during oocyte retrieval has detrimental effect on embryo development and IVF outcomes is unknown.

Previous studies showed that low oxygen tension during embryo culture improved implantation rate and clinical outcomes, but embryo quality was not affected. In other studies, embryo quality was improved but overall pregnancy was not affected. The reason for the discrepancies could be because the oxygen tension during oocyte/embryo manipulation was not under well control. For instance, oocyte retrieval, fertilization check and embryo grading were performed under atmospheric oxygen. It is difficult to predict how these factors negatively impact the IVF outcomes.

In this project, the investigators hypothesize that lower oxygen tension during oocyte/embryo manipulation improves IVF outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the experimental group, oocyte pickup will be performed in a lower oxygen tension environment (5% oxygen, 89% nitrogen, 6% carbon dioxide); oocyte pickup will be performed in a special workstation with reduced oxygen tension environment while fertilization check and embryo grading will be performed in conventional and time lapse embryo culture system. The time lapse culture system can provide a constant lower oxygen tension culture environment to the embryos. In the control group, oocyte pickup, fertilization check and embryo grading will be performed in atmospheric oxygen environment. Under this arrangement, the difference between the 2 groups is the oxygen tension during oocyte/embryo manipulation. The investigators believe that a solid conclusion can be drawn about whether lower oxygen tension environment can benefit IVF outcomes.

Study Type

Interventional

Enrollment (Anticipated)

1160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all the couples undergoing conventional IVF cycle in the reproductive medicine center of the University of Hong Kong-Shenzhen Hospital

Exclusion Criteria:

  • Intracytoplasmic sperm injection (ICSI) cycle
  • Preimplantation genetic testing (PGT) cycle
  • cycle with fertilization failure ≥3
  • cycle using sperm from percutaneous epididymal sperm aspiration (PESA)/testicular sperm extraction (TESE) or cryopreserved sperm
  • cycle using cryopreserved oocyte
  • cycle with no oocyte retrieved

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 20% O2
In the control group, oocyte pickup will be performed in atmospheric oxygen environment (20% oxygen, 89% nitrogen, 6% carbon dioxide).
EXPERIMENTAL: 5% O2
In the experimental group, oocyte pickup will be performed in a low oxygen tension environment (5% oxygen, 89% nitrogen, 6% carbon dioxide). If time lapse embryo culture system is used, fertilization check and embryo grading will also be conducted under the low oxygen tension environment.
Biological: 5% O2
5% oxygen will be used during oocyte retrieval, fertilization check and embryo grading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: 4 years
delivery of a live birth beyond 24 weeks of gestation
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 3 years
presence of at least one gestational sac on ultrasound of 6 weeks
3 years
ongoing pregnancy rate
Time Frame: 3 years
presence of at least heart pulsation on ultrasound beyond 20 weeks
3 years
fertilization rate
Time Frame: 3 years
No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)
3 years
cleavage rate
Time Frame: 3 years
No. of cleaved embryo divided by No. of fertilized oocyte
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong-Shenzhen Hospital

Investigators

  • Principal Investigator: Shubiu Yeung, PhD, The University of Hong Kong-Shenzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 22, 2021

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (ACTUAL)

June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKUSZH201902022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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