Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

Sponsor

Liliana Berenice Ramírez Domínguez (Industry)

Overall Status

Completed

CT.gov ID

NCT05919186

Collaborator

(none)

293

Enrollment

Location

Arms

6.9

Actual Duration (Months)

42.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to investigate the impact of repeated antioxidant supplementation on blastocyst utilization and expansion rates in embryos under different oxygen concentrations. The study aims to answer the following main questions:

Does adding antioxidants every 12 hours to embryo culture media improve usable and expanded blastocyst utilization rates on days 5 and 6?
How are the O2 concentrations related to the effect of different methods of antioxidants supplementation on blastocysts utilization and expansion rates?

Participants in this study are infertile couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles.

Zygotes will be incubated at either 5% or 20% oxygen tension until the blastocyst stage.
Sibling zygotes will be divided into four groups: Group 1A and 1B: Antioxidants every 12 hours at either 5% or 20% O2 tension, respectively. Group 2A and 2B: Antioxidants only once at the beginning of embryo culture at either 5% or 20% O2 tension, respectively.

Researchers will compare the four groups to determine if the repeated antioxidant supplementation of the culture media leads to improved blastocyst utilization and expansion rates compared to the baseline group.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Infertility, Male	Drug: EmbryORP® Device: O2 tension 20% Device: O2 tension 5%	N/A

Detailed Description

This study is focused on the role of antioxidants (AOXs) in mitigating reactive oxygen species and oxidative stress, which have been associated with failure in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). The research aimed to evaluate the effect of two different methods of antioxidants supplementation at two O2 tensions on blastocyst utilization and expansion rates. To achieve this, 3603 zygotes from infertile couples undergoing IVF or ICSI were included in the study. The zygotes were divided into two groups: Group 1A and 1B: Antioxidants every 12 hours at either 5% or 20% O2 tension, respectively. Group 2A and 2B: Antioxidants only once at the beginning of embryo culture at either 5% or 20% O2 tension, respectively.

Study Design

Study Type:

Interventional

Actual Enrollment :

293 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The data registry utilized internal and external measures to ensure accuracy. SOPs were developed for registry operations and data analysis. Data were recorded in clinical records and clinic-specific databases. Regular backups and monthly audits were conducted to safeguard data and verify accuracy. External audits occurred every 6 months. Access controls protected privacy. Appropriate statistical techniques and sample size assessment were used for data analysis. A study on embryo development analyzed 3603 zygotes, assessing blastocyst outcomes and detailing procedures for ovarian stimulation, retrieval, sperm preparation, and assisted reproduction techniques. These measures ensured accurate and reliable results.The data registry utilized internal and external measures to ensure accuracy. SOPs were developed for registry operations and data analysis. Data were recorded in clinical records and clinic-specific databases. Regular backups and monthly audits were conducted to safeguard data and verify accuracy. External audits occurred every 6 months. Access controls protected privacy. Appropriate statistical techniques and sample size assessment were used for data analysis. A study on embryo development analyzed 3603 zygotes, assessing blastocyst outcomes and detailing procedures for ovarian stimulation, retrieval, sperm preparation, and assisted reproduction techniques. These measures ensured accurate and reliable results.

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Impact of Repeated Antioxidant Supplementation of Embryo Culture Media on Blastocyst Utilization and Expansion Rate Under Two Different O2 Concentrations

Actual Study Start Date :

Oct 12, 2021

Actual Primary Completion Date :

Apr 12, 2022

Actual Study Completion Date :

May 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EmrbyORP continued at high O2 Antioxidants supplementation Every 12 hours (3.5 μL)	Drug: EmbryORP® EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM) Other Names: EmbryORP Device: O2 tension 20% After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
Experimental: EmrbyORP at baseline with high O2 Antioxidants supplementation At baseline only (6.5 μL)	Drug: EmbryORP® EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM) Other Names: EmbryORP Device: O2 tension 20% After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
Experimental: EmrbyORP continued at low 02 Antioxidants supplementation Every 12 hours (3.5 μL)	Drug: EmbryORP® EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM) Other Names: EmbryORP Device: O2 tension 5% After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%
Experimental: EmrbyORP at baseline with low o2 Antioxidants supplementation At baseline only (6.5 μL)	Drug: EmbryORP® EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM) Other Names: EmbryORP Device: O2 tension 5% After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%

Outcome Measures

Primary Outcome Measures

Rate of usable blastocysts on day 5 [5 days]
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 5
Rate of expanded blastocysts on day 5 [5 days]
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 5
Rate of sable blastocysts on day 6 [6 days]
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 6
Rate of expanded blastocysts on day 6 [6 days]
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 6
Rate of acumulative usable blastocysts [5 - 6 days]
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at days 5 and 6
Rate of acumulative expanded blastocysts. [5 - 6 days]
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at days 5 and 6

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Infertile women with from 18 to 37 years old at the moment of oocyte collection, tubal factor, polycystic ovary syndrome, uterine factor, or unexplained infertility.
More than 2 oocytes by conventional in vitro fertilization (cIVF) and intracytoplasmic sperm injection (ICSI).

Exclusion Criteria:

Infertile woman in assisted reproduction treatment with less than 2 oocytes collected.
Infertile woman in assisted reproduction treatment with less than 2 oocytes fertilized by conventional in vitro fertilization (cIVF) and intracytoplasmic sperm injection (ICSI)