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

NCT04424784 | Unknown

• 1 other identifier: HKUSZH201902022
• Study Type: interventional
• Target: 1,160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Embryo Hypoxia

Outcome Measures

Primary Outcomes (1)

• live birth rate

  delivery of a live birth beyond 24 weeks of gestation

  4 years

Secondary Outcomes (4)

• clinical pregnancy rate

  3 years

• ongoing pregnancy rate

  3 years

• fertilization rate

  3 years

• cleavage rate

  3 years

Study Arms (2)

20% O2

NO INTERVENTION

In the control group, oocyte pickup will be performed in atmospheric oxygen environment (20% oxygen, 89% nitrogen, 6% carbon dioxide).

5% O2

EXPERIMENTAL

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

Interventions

5% O2 BIOLOGICAL

5% oxygen will be used during oocyte retrieval, fertilization check and embryo grading

5% O2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital: lead

Study Sites (1)

Reproductive medicine center

Shenzhen, China

RECRUITING

Related Publications (3)

• Fischer B, Bavister BD. Oxygen tension in the oviduct and uterus of rhesus monkeys, hamsters and rabbits. J Reprod Fertil. 1993 Nov;99(2):673-9. doi: 10.1530/jrf.0.0990673.

  PMID: 8107053 BACKGROUND

• Kovacic B, Vlaisavljevic V. Influence of atmospheric versus reduced oxygen concentration on development of human blastocysts in vitro: a prospective study on sibling oocytes. Reprod Biomed Online. 2008 Aug;17(2):229-36. doi: 10.1016/s1472-6483(10)60199-x.

  PMID: 18681997 BACKGROUND

• Waldenstrom U, Engstrom AB, Hellberg D, Nilsson S. Low-oxygen compared with high-oxygen atmosphere in blastocyst culture, a prospective randomized study. Fertil Steril. 2009 Jun;91(6):2461-5. doi: 10.1016/j.fertnstert.2008.03.051. Epub 2008 Jun 12.

  PMID: 18554591 BACKGROUND

Study Officials

• Shubiu Yeung, PhD

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Peng, PhD

CONTACT

8675586917836; qianpeng_77@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 11, 2020
• Study Start: March 22, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

CN (1)