Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates.

Infertility Clinical Trial

— GX  

Official title:

Antioxidants-enriched Single-step vs Global Total Single-step Embryo Culture Media: Effect on Blastocyst Euploidy Rates.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261671
• Other study ID #: 2312-ABU-028-VF
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: ART Fertility Clinics LLC
• Contact: Daniela Nogueira
• Phone: +971504374961
• Email: daniela.nogueira[@]artfertilityclinics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.

Description:

Improvements in culture conditions is an ongoing process in IVF due to, on one hand, the still lack of knowledge on human embryonic development, and, on the other hand, the frequent need for repeated IVF cycles to achieve an 'implantable' embryo. The main factor for optimizing conditions of an embryo to develop is its microenvironment, mainly the culture media used. One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment, as it has been extensively shown in animal models and to a certain extent in humans.

A primordial step for improvement is to alleviate an increase in ROS during embryo development. This can be manipulated by means of utilizing a culture media with supplements that can serve as scavengers, leading to an equilibrium between oxidation and reduction of ROS during the culture period. So far, the produced culture media contain low concentrations of limited additives involved in anti-oxidative stress. Recently, a culture medium containing an implementation in higher doses of distinctive elements known to clearly serve as cellular scavengers has been formulated. However, very few human IVF studies have been performed up to date. Our research intends to investigate the incorporation of antioxidant-rich culture media into IVF practices with the primary objective of analyzing its impact on embryo euploidy, as well as the previous culture steps including fertilization and blastocyst developmental rates. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Patients undergoing assisted reproductive technology cycles when ICSI is indicated.

• Patients when Iin vitto fertilization (IVF) is also performed will be included as far as there are enough oocytes for ICSI randomization. However, IVF oocytes will not be used for the study.

• Maternal age 18-43 years old.

• PGT-A cycles with only trophectoderm biopsies on day 5/6/7.

• Patients with more than 6 COCs expected for ICSI.

• Body mass index <35.

• Fresh and frozen ejaculated sperm.

Exclusion Criteria:

• PGT-M cycles

• Fresh and frozen testicular sperm.

Related Conditions & MeSH terms

• In Vitro Fertilization
• Infertility

Intervention

Drug:
• antioxidants-enriched culture medium (Gx)
Blastocyst will be in continuous culture conditions (parallel antioxidants-enriched culture medium (Gx) and Global total one step media (GT) without refreshment on day 3. A refreshment of the media will be done on D5 in both groups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ART Fertility Clinics LLC

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastocyst ploidy is determined after a biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. The following outcomes are possible: • Normal • Abnormal • No result/Inconclusive • Low or high Mosaic	Ploidy rate is calculated by dividing the number of normal embryos by the number of blastocysts biopsied in the group.	1 year
Secondary	Cycle ploidy rate: the number of euploid embryos in the group Blastocyst quality at the time of biopsy based on modified Gardner's criteria. Usable blastocyst rate per group and per day of biopsy (day 5, 6, 7)	Ploidy rate is calculated by dividing the number of normal embryos by the number of blastocysts biopsied in the group.	1 year