Effects of Antioxidant Supplementation of Culture Media on IVF Embryos
- Conditions
- Infertility, FemaleInfertility, Male
- Interventions
- Drug: EmbryORP®Device: O2 tension 20%Device: O2 tension 5%
- Registration Number
- NCT05919186
- Lead Sponsor
- Liliana Berenice Ramírez Domínguez
- 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.
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Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 293
- 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).
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EmrbyORP continued at high O2 EmbryORP® Antioxidants supplementation Every 12 hours (3.5 μL) EmrbyORP at baseline with high O2 O2 tension 20% Antioxidants supplementation At baseline only (6.5 μL) EmrbyORP continued at low 02 EmbryORP® Antioxidants supplementation Every 12 hours (3.5 μL) EmrbyORP at baseline with low o2 O2 tension 5% Antioxidants supplementation At baseline only (6.5 μL) EmrbyORP continued at high O2 O2 tension 20% Antioxidants supplementation Every 12 hours (3.5 μL) EmrbyORP at baseline with high O2 EmbryORP® Antioxidants supplementation At baseline only (6.5 μL) EmrbyORP continued at low 02 O2 tension 5% Antioxidants supplementation Every 12 hours (3.5 μL) EmrbyORP at baseline with low o2 EmbryORP® Antioxidants supplementation At baseline only (6.5 μL)
- Primary Outcome Measures
Name Time Method 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 6 6 days Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 6
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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CITMER
🇲🇽Mexico City, Mexico