Infertility, FemaleNCT05676515
Evaluation of Different Culture Media for in Vitro Fertilization
A study testing culture media in people with Infertility, Female, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Under in vivo conditions, human gametes and embryos are exposed to fluids in the fallopian tubes, where fertilization occurs, and in the uterus, the site of embryonic implantation. The composition of these microenvironments is extremely complex and diverse. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- culture media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Oct 2022to 31 Mar 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- IVF/ICSI cycles;
- At least three oocytes retrieved;
- Consent term signed;
Who cannot join
- Less than three oocytes for fertilization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Culture Media for in Vitro Fertilization: a Randomized Clinical Trial
Under in vivo conditions, human gametes and embryos are exposed to fluids in the fallopian tubes, where fertilization occurs, and in the uterus, the site of embryonic implantation. The composition of these microenvironments is extremely complex and diverse. On the other hand, infertile couples who need in vitro fertilization treatments have their gametes and embryos cultured for a few days in commercial culture media. The composition of the media used in assisted reproduction laboratories varies according to the manufacturer and culture strategy. It is already known that the exposure of embryos to different concentrations of nutrients can affect the effectiveness of in vitro fertilization treatments, such as the fertilization rate, embryonic development speed, implantation rate, gestation, abortion, newborn weight, among other factors. Although these aspects are much discussed in the literature, there is still no consensus regarding the choice of a specific culture medium. Thus, the present study aims to evaluate the influence of three commercial culture media on the fertilization rate and embryonic quality through a prospective randomized clinical trial using sibling oocytes from patients undergoing in vitro fertilization cycles.
Read the detailed description
For this prospective randomized clinical trial, patients undergoing IVF cycles with at least three oocytes obtained from ovarian aspiration procedure will be enrolled. Considering a 30% difference between the groups in the number of good quality embryos (A + B) with power of 80% and p alpha 5%, the n calculated was 95 oocytes for each group, totaling 285 oocytes retrieved and 48 patients, as the mean number of oocytes per patient is 6.
The two main parameters that will be evaluated are:
Fertilization rate: An oocyte with 2 pronuclei and 2 polar bodies formed (2PN/2CPs) is considered fertilized. The evaluation of oocyte fertilization rates in three tested media will be measured by the percentage of 2PN/2CPs zygotes observed in the check between 16-18 hours after fertilization by IVF or ICSI.
Embryo quality: Embryos will be classified as A, B, C or D according to the scheme below, with A and B embryos being considered good quality embryos. The evaluation of embryonic quality will be carried out on the third day (64-67 hours after fertilization) taking into account the parameters of cell number, symmetry and fragmentation.
Embryo quality was defined as the primary outcome of this study because it is a parameter directly related to the prognosis of in vitro fertilization treatment, and it has a predefined value in the Vienna consensus being commonly described in scientific articles.
Fertilization rates and good quality embryos will be expressed as percentages (mean and standard deviation). The chi-square test will be used to compare fertilization and embryonic quality between the culture media and the difference will be considered significant if p < 0.05. For tabulation and statistical analysis, the JASP software version 0.16.2 will be used.
- Conditions
- Infertility, Female
- Being tested
- culture media
- Keywords
- culture media, fertilization
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culture mediaOther
spliting of biological material and use of three culture media
| Study group | Role | What they receive |
|---|---|---|
| culture media of fabricant A | Active comparator | use of culture media of fabricant A Receives: Other: culture media |
| culture media of fabricant B | Active comparator | use of culture media of fabricant B Receives: Other: culture media |
| culture media of fabricant C | Active comparator | use of culture media of fabricant C Receives: Other: culture media |
What is being measured
The primary outcome is the main question the study is designed to answer.
day three good quality embryo rate
day three A/B embryos
Measured: 64-67 hours
Secondary outcomes (1)
fertilization
presence of 2 pronuclei and 2 polar bodies
Measured: 16-18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start10 Oct 2022
- Primary completion1 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Guedes da Luz Médicos Associados Sociedade Simples LTDA
- Responsible party
- Sponsor
- Investigators
- João Sabino Cunha Filho, PhD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676515
- Sponsor's protocol ID
- 60500922.2.0000.5327
- Status last verified
- Feb 2024
- First submitted
- 22 Dec 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Culture Media for in Vitro Fertilization: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05676515
- Acronym / sponsor ID
- 60500922.2.0000.5327
- Conditions
- Infertility, Female
- Keywords
- culture media, fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Guedes da Luz Médicos Associados Sociedade Simples LTDA
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 9 Jan 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.
Under in vivo conditions, human gametes and embryos are exposed to fluids in the fallopian tubes, where fertilization occurs, and in the uterus, the site of embryonic implantation. The composition of these microenvironments is extremely complex and diverse. On the other hand, infertile couples who need in vitro fertilization treatments have their gametes and embryos cultured for a few days in commercial culture media. The composition of the media used in assisted reproduction laboratories varies according to the manufacturer and culture strategy. It is already known that the exposure of embryos to different concentrations of nutrients can affect the effectiveness of in vitro fertilization treatments, such as the fertilization rate, embryonic development speed, implantation rate, gestation, abortion, newborn weight, among other factors. Although these aspects are much discussed in the literature, there is still no consensus regarding the choice of a specific culture medium. Thus, the present study aims to evaluate the influence of three commercial culture media on the fertilization rate and embryonic quality through a prospective randomized clinical trial using sibling oocytes from patients undergoing in vitro fertilization cycles.
Detailed description
For this prospective randomized clinical trial, patients undergoing IVF cycles with at least three oocytes obtained from ovarian aspiration procedure will be enrolled. Considering a 30% difference between the groups in the number of good quality embryos (A + B) with power of 80% and p alpha 5%, the n calculated was 95 oocytes for each group, totaling 285 oocytes retrieved and 48 patients, as the mean number of oocytes per patient is 6.
The two main parameters that will be evaluated are:
Fertilization rate: An oocyte with 2 pronuclei and 2 polar bodies formed (2PN/2CPs) is considered fertilized. The evaluation of oocyte fertilization rates in three tested media will be measured by the percentage of 2PN/2CPs zygotes observed in the check between 16-18 hours after fertilization by IVF or ICSI.
Embryo quality: Embryos will be classified as A, B, C or D according to the scheme below, with A and B embryos being considered good quality embryos. The evaluation of embryonic quality will be carried out on the third day (64-67 hours after fertilization) taking into account the parameters of cell number, symmetry and fragmentation.
Embryo quality was defined as the primary outcome of this study because it is a parameter directly related to the prognosis of in vitro fertilization treatment, and it has a predefined value in the Vienna consensus being commonly described in scientific articles.
Fertilization rates and good quality embryos will be expressed as percentages (mean and standard deviation). The chi-square test will be used to compare fertilization and embryonic quality between the culture media and the difference will be considered significant if p < 0.05. For tabulation and statistical analysis, the JASP software version 0.16.2 will be used.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| culture media of fabricant A | Active comparator | Other: culture mediause of culture media of fabricant A |
| culture media of fabricant B | Active comparator | Other: culture mediause of culture media of fabricant B |
| culture media of fabricant C | Active comparator | Other: culture mediause of culture media of fabricant C |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- IVF/ICSI cycles;
- At least three oocytes retrieved;
- Consent term signed;
Key exclusion criteria (1 listed)
- Less than three oocytes for fertilization.
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 |
|---|---|---|
| culture mediaspliting of biological material and use of three culture media | Other | culture media of fabricant A, culture media of fabricant B, culture media of fabricant C |
Primary outcome
day three good quality embryo rate
Time frame: 64-67 hours
day three A/B embryos
1 secondary outcome
fertilization
Time frame: 16-18 hours
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 28 Feb 2024.
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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.
João Sabino Cunha Filho, PhD study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing culture media in people with Infertility, Female, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 inclusion and 1 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 28 Feb 2024. 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 Brazil. 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?
day three good quality embryo rate (time frame: 64-67 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.