Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates. (GX)

ART Fertility Clinics LLC

Status: Enrolling

Conditions: In Vitro Fertilization; Infertility

Treatments: Drug: antioxidants-enriched culture medium (Gx)

Study type: Interventional

Funder types: Other

Identifiers

NCT06261671

2312-ABU-028-VF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Group 1: antioxidants-enriched culture medium (Gx)

Active Comparator group

Description:

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.

Treatment:

Drug: antioxidants-enriched culture medium (Gx)

Group 2: Global total one step media (GT)

Active Comparator group

Description:

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.

Treatment:

Drug: antioxidants-enriched culture medium (Gx)