Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates.

NCT06261671 | Recruiting

• 1 other identifier: 2312-ABU-028-VF
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility; In Vitro Fertilization

Keywords

Intracytoplasmic sperm injection; Pre - implanttaion genetic diagnosis for aneuploidy; Antioxydante; Culture media; Embryo development; Euploidy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

  1 year

Study Arms (2)

Group 1: antioxidants-enriched culture medium (Gx)

ACTIVE COMPARATOR

Blastocyst exposed to antioxidants-enriched culture medium (Gx) in continuous culture conditions, without refreshment on day 3. A refreshment of the media will be done on D5 in both groups.

Drug: antioxidants-enriched culture medium (Gx)

Group 2: Global total one step media (GT)

ACTIVE COMPARATOR

Blastocyst exposed to Global total one step media (GT) in continuous culture conditions, without refreshment on day 3. A refreshment of the media will be done on D5 in both groups.

Drug: antioxidants-enriched culture medium (Gx)

Interventions

antioxidants-enriched culture medium (Gx) DRUG

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.

Also known as: Global total one step media (GT)

Group 1: antioxidants-enriched culture medium (Gx); Group 2: Global total one step media (GT)

Eligibility Criteria

• Age: 18 Years - 43 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• PGT-M cycles
• Fresh and frozen testicular sperm.

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Barbara Lawrenz

  ART Fertility Clinics LLC

  STUDY DIRECTOR

Central Study Contacts

Daniela Nogueira

CONTACT

+971504374961; daniela.nogueira@artfertilityclinics.com

Jonalyn DV Edades

CONTACT

+971526408688; jonalyn.ededas@artfertilityclinics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomization list (indicating Gx Media Vitrolife or GT Coopersurgical) will be used to verify to which group the first half of oocytes will be allocated to. In case an odd number of oocytes is present, one extra oocyte is allocated to the group as indicated by the randomization list.

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

AE (1)