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Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

Primary Purpose

Infertility, Female, Infertility, Male

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
EmbryORP®
O2 tension 20%
O2 tension 5%
Sponsored by
Liliana Berenice Ramírez Domínguez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infertility, Female focused on measuring Blastocyst Rate, IVF, Embryo Culture, Antioxidants

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept 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)

Sites / Locations

  • CITMER

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

EmrbyORP continued at high O2

EmrbyORP at baseline with high O2

EmrbyORP continued at low 02

EmrbyORP at baseline with low o2

Arm Description

Antioxidants supplementation Every 12 hours (3.5 μL)

Antioxidants supplementation At baseline only (6.5 μL)

Antioxidants supplementation Every 12 hours (3.5 μL)

Antioxidants supplementation At baseline only (6.5 μL)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2023
Last Updated
June 22, 2023
Sponsor
Liliana Berenice Ramírez Domínguez
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1. Study Identification

Unique Protocol Identification Number
NCT05919186
Brief Title
Effects of Antioxidant Supplementation of Culture Media on IVF Embryos
Official Title
Impact of Repeated Antioxidant Supplementation of Embryo Culture Media on Blastocyst Utilization and Expansion Rate Under Two Different O2 Concentrations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
April 12, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liliana Berenice Ramírez Domínguez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Infertility, Male
Keywords
Blastocyst Rate, IVF, Embryo Culture, Antioxidants

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EmrbyORP continued at high O2
Arm Type
Experimental
Arm Description
Antioxidants supplementation Every 12 hours (3.5 μL)
Arm Title
EmrbyORP at baseline with high O2
Arm Type
Experimental
Arm Description
Antioxidants supplementation At baseline only (6.5 μL)
Arm Title
EmrbyORP continued at low 02
Arm Type
Experimental
Arm Description
Antioxidants supplementation Every 12 hours (3.5 μL)
Arm Title
EmrbyORP at baseline with low o2
Arm Type
Experimental
Arm Description
Antioxidants supplementation At baseline only (6.5 μL)
Intervention Type
Drug
Intervention Name(s)
EmbryORP®
Other Intervention Name(s)
EmbryORP
Intervention Description
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
Intervention Type
Device
Intervention Name(s)
O2 tension 20%
Intervention Description
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
Intervention Type
Device
Intervention Name(s)
O2 tension 5%
Intervention Description
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%
Primary Outcome Measure Information:
Title
Rate of usable blastocysts on day 5
Description
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 5
Time Frame
5 days
Title
Rate of expanded blastocysts on day 5
Description
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 5
Time Frame
5 days
Title
Rate of sable blastocysts on day 6
Description
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 6
Time Frame
6 days
Title
Rate of expanded blastocysts on day 6
Description
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 6
Time Frame
6 days
Title
Rate of acumulative usable blastocysts
Description
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at days 5 and 6
Time Frame
5 - 6 days
Title
Rate of acumulative expanded blastocysts.
Description
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at days 5 and 6
Time Frame
5 - 6 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Agarwal, PhD
Organizational Affiliation
Global Andrology Forum
Official's Role
Study Director
Facility Information:
Facility Name
CITMER
City
Mexico City
ZIP/Postal Code
11520
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

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