Actively Recruiting

Phase Not Applicable
Age: 18Years - 43Years
All Genders
Healthy Volunteers
ID06261671

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

Led by ART Fertility Clinics LLC · Updated on 2025-02-21

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the impact of antioxidant-enriched culture media on embryo development during in vitro fertilization (IVF). The study focuses on how reactive oxidative species (ROS) generated in the artificial IVF environment may affect gametes and embryos, potentially influencing embryo quality and development. This prospective randomized trial uses sibling oocytes to assess how antioxidant supplements in culture media might improve embryo ploidy rates, fertilization, and blastocyst development. Participants' embryos will be cultured using two different media: one enriched with antioxidants (Gx) and the other using the Global total one step media (GT). Both groups will be cultured continuously without media refreshment on day 3, but the media will be refreshed on day 5. The study compares the effects of these two culture media on embryo development through IVF procedures. During the study, embryos will be biopsied on days 5, 6, or 7 to assess blastocyst ploidy by examining trophectoderm cells. Researchers will monitor outcomes such as normal or abnormal ploidy, inconclusive results, and mosaicism levels. Secondary outcomes include the quality of blastocysts at biopsy and usable blastocyst rates per group. The study will last up to one year, with participants undergoing IVF cycles involving intracytoplasmic sperm injection (ICSI) and having multiple assessments of embryo development and quality.

CONDITIONS

Brief Title

Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates.

Who Can Participate

Age: 18Years - 43Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing assisted reproductive technology cycles when ICSI is indicated
  • Patients undergoing IVF included if enough oocytes are available for ICSI randomization; IVF oocytes not used
  • Maternal age between 18 and 43 years old
  • PGT-A cycles with trophectoderm biopsies on day 5, 6, or 7
  • Patients expected to have more than 6 cumulus-oocyte complexes (COCs) for ICSI
  • Body mass index less than 35
  • Use of fresh or frozen ejaculated sperm
Not Eligible

You will not qualify if you...

  • PGT-M cycles
  • Use of fresh or frozen testicular sperm

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 7 days of embryo development

Participants undergo IVF with oocytes cultured in either antioxidants-enriched or standard culture media to assess embryo development and euploidy rates.

1 IVF cycle with embryo culture and biopsy on day 5, 6, or 7

Trial Site Locations

Total: 1 location

1

ART Fertility Clinics LLC

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

Actively Recruiting

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Research Team

D

Daniela Nogueira

J

Jonalyn DV Edades

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

International Committee for Monitoring Assisted Reproductive Technologies world report: assisted reproductive technology, 2014†.

Georgina M Chambers, Silke Dyer, Fernando Zegers-Hochschild...

https://pubmed.ncbi.nlm.nih.gov/34601605

Antioxidant supplementation overcomes the deleterious effects of maternal restraint stress-induced oxidative stress on mouse oocytes.

Hua-Yu Lian, Yan Gao, Guang-Zhong Jiao...

https://pubmed.ncbi.nlm.nih.gov/24043846