Infertility, FemaleNCT05919186
Effects of Antioxidant Supplementation of Culture Media on IVF Embryos
A study testing EmbryORP®, O2 tension 20% and O2 tension 5% in people with Infertility, Female and Infertility, Male, run by Liliana Berenice Ramírez Domínguez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility, Female, Infertility, Male
- What is being tested?
- EmbryORP®, O2 tension 20% and O2 tension 5%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteMexico
- Study dates
- 12 Oct 2021to 10 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Repeated Antioxidant Supplementation of Embryo Culture Media on Blastocyst Utilization and Expansion Rate Under Two Different O2 Concentrations
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?
Read more
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.
Read the 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.
.
- Conditions
- Infertility, Female, Infertility, Male
- Being tested
- EmbryORP®, O2 tension 20%, O2 tension 5%
- Keywords
- Blastocyst Rate, IVF, Embryo Culture, Antioxidants
- Medical subject headings
- Infertility, Female, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbryORP®Drug
Also called EmbryORP
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
O2 tension 20%Device
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
O2 tension 5%Device
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%
| Study group | Role | What they receive |
|---|---|---|
| EmrbyORP continued at high O2 | Experimental | Antioxidants supplementation Every 12 hours (3.5 μL) Receives: Drug: EmbryORP®; Device: O2 tension 20% |
| EmrbyORP at baseline with high O2 | Experimental | Antioxidants supplementation At baseline only (6.5 μL) Receives: Drug: EmbryORP®; Device: O2 tension 20% |
| EmrbyORP continued at low 02 | Experimental | Antioxidants supplementation Every 12 hours (3.5 μL) Receives: Drug: EmbryORP®; Device: O2 tension 5% |
| EmrbyORP at baseline with low o2 | Experimental | Antioxidants supplementation At baseline only (6.5 μL) Receives: Drug: EmbryORP®; Device: O2 tension 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of usable blastocysts on day 5
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 5
Measured: 5 days
Rate of expanded blastocysts on day 5
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 5
Measured: 5 days
Rate of sable blastocysts on day 6
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 6
Measured: 6 days
Rate of expanded blastocysts on day 6
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 6
Measured: 6 days
Rate of acumulative usable blastocysts
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at days 5 and 6
Measured: 5 - 6 days
Rate of acumulative expanded blastocysts.
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at days 5 and 6
Measured: 5 - 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start12 Oct 2021
- Primary completion12 Apr 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liliana Berenice Ramírez Domínguez
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Liliana Berenice Ramírez Domínguez, Center of Innovation Technology & Reproductive Medicine
- Investigators
- Ashok Agarwal, PhD, Study director, Global Andrology Forum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919186
- Sponsor's protocol ID
- CI-20-102
- Status last verified
- Jun 2023
- First submitted
- 12 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khalied Kaskar, C. Optimizing embryo culture conditions and spent culture media analysis as predictors of em-bryo quality and pregnancy; PhD Thesis, University of the West Cape, Cape Town, South Africa, February 2021.
Swain JE. Optimizing the culture environment in the IVF laboratory: impact of pH and buffer capacity on gamete and embryo quality. Reprod Biomed Online. 2010 Jul;21(1):6-16. doi: 10.1016/j.rbmo.2010.03.012. Epub 2010 Mar 21.
PubMed 20570214Lane M, Lyons EA, Bavister BD. Cryopreservation reduces the ability of hamster 2-cell embryos to regulate intracellular pH. Hum Reprod. 2000 Feb;15(2):389-94. doi: 10.1093/humrep/15.2.389.
PubMed 10655311Nastri CO, Nobrega BN, Teixeira DM, Amorim J, Diniz LMM, Barbosa MWP, Giorgi VSI, Pileggi VN, Martins WP. Low versus atmospheric oxygen tension for embryo culture in assisted reproduction: a systematic review and meta-analysis. Fertil Steril. 2016 Jul;106(1):95-104.e17. doi: 10.1016/j.fertnstert.2016.02.037. Epub 2016 Mar 21.
PubMed 27012651Edwards LJ, Williams DA, Gardner DK. Intracellular pH of the preimplantation mouse embryo: effects of extracellular pH and weak acids. Mol Reprod Dev. 1998 Aug;50(4):434-42. doi: 10.1002/(SICI)1098-2795(199808)50:43.0.CO;2-J.
PubMed 9669527Hong KH, Lee H, Forman EJ, Upham KM, Scott RT Jr. Examining the temperature of embryo culture in in vitro fertilization: a randomized controlled trial comparing traditional core temperature (37 degrees C) to a more physiologic, cooler temperature (36 degrees C). Fertil Steril. 2014 Sep;102(3):767-73. doi: 10.1016/j.fertnstert.2014.06.009. Epub 2014 Jul 17.
PubMed 25044079Chui, A.; Kalionis, B.; Brennecke, S.; Murthi, P. 201 Homeobox Gene DLX3 Regulates Forskolin Induced Tropho-blast Differentiation. Reprod Fertil Dev 2008, 20(9), 1-1
Agarwal A, Gupta S, Sharma RK. Role of oxidative stress in female reproduction. Reprod Biol Endocrinol. 2005 Jul 14;3:28. doi: 10.1186/1477-7827-3-28.
PubMed 16018814Carocho M, Ferreira IC. A review on antioxidants, prooxidants and related controversy: natural and synthetic compounds, screening and analysis methodologies and future perspectives. Food Chem Toxicol. 2013 Jan;51:15-25. doi: 10.1016/j.fct.2012.09.021. Epub 2012 Sep 24.
PubMed 23017782Guerin P, El Mouatassim S, Menezo Y. Oxidative stress and protection against reactive oxygen species in the pre-implantation embryo and its surroundings. Hum Reprod Update. 2001 Mar-Apr;7(2):175-89. doi: 10.1093/humupd/7.2.175.
PubMed 11284661Budani MC, Tiboni GM. Effects of Supplementation with Natural Antioxidants on Oocytes and Preimplantation Embryos. Antioxidants (Basel). 2020 Jul 12;9(7):612. doi: 10.3390/antiox9070612.
PubMed 32664650Coria-Gomez CR, Torres-Rodriguez P, Villar-Munoz LG, Jimenez-Medina I, Agarwal A, Henkel R, Maldonado-Rosas I, L Trevino C. Comparative study of fertility parameters in vitrified human spermatozoa in the presence or absence of EmbryORP(R) : A novel antioxidant. Andrologia. 2021 May;53(4):e13886. doi: 10.1111/and.13886. Epub 2021 Feb 7.
PubMed 33550605David Gardner; William Schoolcraft. In Vitro Culture of Human Blastocysts. In Towards Reproductive Certainity: Fertility and Genetics Beyond 1999: The Plenary Proceedings of the 11th World Congress on In Vitro Fertilization & Hu-man Reproductive Genetics; Jansen, R., Mortimer, D., Eds.; Parthenon Publishing Group: London, 1999; Vol. 1, pp. 378-388.
Sallam, N.; Hegab, M.; Mohamed, F.; El-Kaffash, D. Effect of Oxidative Stress in Semen, Follicular Fluid and Em-bryo Culture Medium on the Outcome of Assisted Reproduction. Al-Azhar Internat Med J 2021, 2(7), 59-65, doi:10.21608/aimj.2021.79536.1495
Truong T, Gardner DK. Antioxidants improve IVF outcome and subsequent embryo development in the mouse. Hum Reprod. 2017 Dec 1;32(12):2404-2413. doi: 10.1093/humrep/dex330.
PubMed 29136144
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Repeated Antioxidant Supplementation of Embryo Culture Media on Blastocyst Utilization and Expansion Rate Under Two Different O2 Concentrations
- ClinicalTrials.gov ID
- NCT05919186
- Acronym / sponsor ID
- CI-20-102
- Conditions
- Infertility, Female, Infertility, Male
- Keywords
- Blastocyst Rate, IVF, Embryo Culture, Antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Liliana Berenice Ramírez DomínguezIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| EmrbyORP continued at high O2 | Experimental | Drug: EmbryORP®, Device: O2 tension 20%Antioxidants supplementation Every 12 hours (3.5 μL) |
| EmrbyORP at baseline with high O2 | Experimental | Drug: EmbryORP®, Device: O2 tension 20%Antioxidants supplementation At baseline only (6.5 μL) |
| EmrbyORP continued at low 02 | Experimental | Drug: EmbryORP®, Device: O2 tension 5%Antioxidants supplementation Every 12 hours (3.5 μL) |
| EmrbyORP at baseline with low o2 | Experimental | Drug: EmbryORP®, Device: O2 tension 5%Antioxidants supplementation At baseline only (6.5 μL) |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbryORP®Also: EmbryORPEmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM) | Drug | EmrbyORP at baseline with high O2, EmrbyORP at baseline with low o2, EmrbyORP continued at high O2, EmrbyORP continued at low 02 |
| O2 tension 20%After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95% | Device | EmrbyORP at baseline with high O2, EmrbyORP continued at high O2 |
| O2 tension 5%After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95% | Device | EmrbyORP at baseline with low o2, EmrbyORP continued at low 02 |
Primary outcome
Rate of usable blastocysts on day 5
Time frame: 5 days
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 5
Rate of expanded blastocysts on day 5
Time frame: 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
Time frame: 6 days
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 6
Rate of expanded blastocysts on day 6
Time frame: 6 days
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 6
Rate of acumulative usable blastocysts
Time frame: 5 - 6 days
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at days 5 and 6
Rate of acumulative expanded blastocysts.
Time frame: 5 - 6 days
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at days 5 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- BackgroundKhalied Kaskar, C. Optimizing embryo culture conditions and spent culture media analysis as predictors of em-bryo quality and pregnancy; PhD Thesis, University of the West Cape, Cape Town, South Africa, February 2021.
- Background: PubMed 20570214Swain JE. Optimizing the culture environment in the IVF laboratory: impact of pH and buffer capacity on gamete and embryo quality. Reprod Biomed Online. 2010 Jul;21(1):6-16. doi: 10.1016/j.rbmo.2010.03.012. Epub 2010 Mar 21.
- Background: PubMed 10655311Lane M, Lyons EA, Bavister BD. Cryopreservation reduces the ability of hamster 2-cell embryos to regulate intracellular pH. Hum Reprod. 2000 Feb;15(2):389-94. doi: 10.1093/humrep/15.2.389.
- Background: PubMed 27012651Nastri CO, Nobrega BN, Teixeira DM, Amorim J, Diniz LMM, Barbosa MWP, Giorgi VSI, Pileggi VN, Martins WP. Low versus atmospheric oxygen tension for embryo culture in assisted reproduction: a systematic review and meta-analysis. Fertil Steril. 2016 Jul;106(1):95-104.e17. doi: 10.1016/j.fertnstert.2016.02.037. Epub 2016 Mar 21.
- Background: PubMed 9669527Edwards LJ, Williams DA, Gardner DK. Intracellular pH of the preimplantation mouse embryo: effects of extracellular pH and weak acids. Mol Reprod Dev. 1998 Aug;50(4):434-42. doi: 10.1002/(SICI)1098-2795(199808)50:43.0.CO;2-J.
- Background: PubMed 25044079Hong KH, Lee H, Forman EJ, Upham KM, Scott RT Jr. Examining the temperature of embryo culture in in vitro fertilization: a randomized controlled trial comparing traditional core temperature (37 degrees C) to a more physiologic, cooler temperature (36 degrees C). Fertil Steril. 2014 Sep;102(3):767-73. doi: 10.1016/j.fertnstert.2014.06.009. Epub 2014 Jul 17.
- BackgroundChui, A.; Kalionis, B.; Brennecke, S.; Murthi, P. 201 Homeobox Gene DLX3 Regulates Forskolin Induced Tropho-blast Differentiation. Reprod Fertil Dev 2008, 20(9), 1-1
- Background: PubMed 16018814Agarwal A, Gupta S, Sharma RK. Role of oxidative stress in female reproduction. Reprod Biol Endocrinol. 2005 Jul 14;3:28. doi: 10.1186/1477-7827-3-28.
- Background: PubMed 23017782Carocho M, Ferreira IC. A review on antioxidants, prooxidants and related controversy: natural and synthetic compounds, screening and analysis methodologies and future perspectives. Food Chem Toxicol. 2013 Jan;51:15-25. doi: 10.1016/j.fct.2012.09.021. Epub 2012 Sep 24.
- Background: PubMed 11284661Guerin P, El Mouatassim S, Menezo Y. Oxidative stress and protection against reactive oxygen species in the pre-implantation embryo and its surroundings. Hum Reprod Update. 2001 Mar-Apr;7(2):175-89. doi: 10.1093/humupd/7.2.175.
- Background: PubMed 32664650Budani MC, Tiboni GM. Effects of Supplementation with Natural Antioxidants on Oocytes and Preimplantation Embryos. Antioxidants (Basel). 2020 Jul 12;9(7):612. doi: 10.3390/antiox9070612.
- Background: PubMed 33550605Coria-Gomez CR, Torres-Rodriguez P, Villar-Munoz LG, Jimenez-Medina I, Agarwal A, Henkel R, Maldonado-Rosas I, L Trevino C. Comparative study of fertility parameters in vitrified human spermatozoa in the presence or absence of EmbryORP(R) : A novel antioxidant. Andrologia. 2021 May;53(4):e13886. doi: 10.1111/and.13886. Epub 2021 Feb 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Agarwal, PhD study director
Global Andrology Forum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmbryORP®, O2 tension 20% and O2 tension 5% in people with Infertility, Female and Infertility, Male, run by Liliana Berenice Ramírez Domínguez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of usable blastocysts on day 5 (time frame: 5 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919186, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.