Infertility, FemaleNCT05683639
Heated and Non Heated Ovarian Aspiration Needle Protocol
A study testing warming of the follicular aspiration needle in people with Infertility, Female, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The success of IVF is influenced by factors as cause of infertility and age. Furthermore, there is a large influence of external factors, from the laboratory environment, handling and cultivation of gametes and embryos. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- warming of the follicular aspiration needle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2023to 1 Jun 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
- All women submitted to IVF cycles
Who cannot join
- Women submitted to follicular aspiration due to oocyte cryopreservation
- Patients without oocyte retrieved
- Patients without mature oocyte retrieved
- Procedures with needle replacement
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Insemine Human Reproduction Centre
Porto Alegre, Rio Grande do Sul, 91330-001
About this study
Official title: Randomized Clinical Trial in Women Submitted to in Vitro Fertilization: Warming Versus Not Warming of the Follicular Aspiration Needle.
The success of IVF is influenced by factors as cause of infertility and age. Furthermore, there is a large influence of external factors, from the laboratory environment, handling and cultivation of gametes and embryos. The existence of factors capable of affecting the success of the treatment lead to the need of a quality control to attenuate the unfavorable effects.
After ovarian stimulation, follicular aspiration is performed. At this moment, factors such as aspiration technique, needle type and temperature are the main variables to be controlled. It is known that oocytes are the more sensitive cells to temperature fluctuations. Currently, the standard protocol for follicular aspiration does not include the warming of the aspiration needle. However, due to the existing evidence in the literature, that the follicular fluid temperature drops during the aspiration procedure, this work aims to evaluate the influence of a pre warming of the aspiration needle as a new protocol.
Read the detailed description
The estimated sample was 600 oocytes for each group, totaling a minimum of 1200 oocytes, considering a fertilization rate of 65% in the control group and 73% in the study group, for a power of 80% and p alpha 5%, i.e. , an increase of more than 10% between groups. As there is no data in the literature, when the investigators have this sample an interim analysis to evaluate the data will be performed. The investigators consider 10% a reasonable difference that can (with this sample size) increase by 48 embryos and a possible increase of 7 pregnancies within this sample. Bearing in mind that the average number of oocytes retrieved per patient is 6 oocytes, the investigators estimate that 200 patients will be needed to reach the calculated sample number.
The warm-up protocol will be applied by the embryologists, which consists of heating the follicular aspiration needle to 37 Celsius, overnight, the day before the day of the ovarian aspiration procedure.
The variables that will be compared between the studied groups are the rates of oocyte retrieval, maturity (MII), fracture, atresia, fertilization rates and discarded embryos.
Continuous variables will be analyzed using Student's t test if they have normal distribution, for comparison of means between two independent groups or the Wilcoxon-Mann-Whitney U test if not parametric. Differences between groups will be considered significant when p<0.05.
- Conditions
- Infertility, Female
- Being tested
- warming of the follicular aspiration needle
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warming of the follicular aspiration needleOther
the follicular aspiration needle will be heated overnight before the ovarian aspiration procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard protocol | No intervention | The standard protocol comprises no heating of the aspiration needle. |
| Warming protocol | Experimental | The aspiration needle will be warm-up overnight the day before the oocyte pick-up procedure Receives: Other: warming of the follicular aspiration needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
normal fertilization rate
Fertilization will be confirmed through the visualization of the presence of two pronuclei
Measured: 16 to 18 hours after fertilization procedure
Secondary outcomes (4)
number of oocyte retrieved
the total number of oocytes captured in the ovarian aspiration procedure
Measured: immediately after ovarian aspiration procedure
number of mature oocyte
total number of MII
Measured: 3 hours post ovarian aspiration
oocyte damage rate
the number of fractured oocytes or atresia
Measured: 3 hours post ovarian aspiration
abnormal fertilization rate
the total number of zygotes with three or more pronuclei
Measured: 16 to 18 hours after fertilization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start2 Jan 2023
- Primary completion1 Mar 2023
- Study completion1 Jun 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
- 179 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 da Cunha Filho, PhD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683639
- Sponsor's protocol ID
- 60504522.7.0000.5327
- Status last verified
- Mar 2024
- First submitted
- 22 Dec 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial in Women Submitted to in Vitro Fertilization: Warming Versus Not Warming of the Follicular Aspiration Needle.
- ClinicalTrials.gov ID
- NCT05683639
- Acronym / sponsor ID
- 60504522.7.0000.5327
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Guedes da Luz Médicos Associados Sociedade Simples LTDA
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 13 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.
The success of IVF is influenced by factors as cause of infertility and age. Furthermore, there is a large influence of external factors, from the laboratory environment, handling and cultivation of gametes and embryos. The existence of factors capable of affecting the success of the treatment lead to the need of a quality control to attenuate the unfavorable effects.
After ovarian stimulation, follicular aspiration is performed. At this moment, factors such as aspiration technique, needle type and temperature are the main variables to be controlled. It is known that oocytes are the more sensitive cells to temperature fluctuations. Currently, the standard protocol for follicular aspiration does not include the warming of the aspiration needle. However, due to the existing evidence in the literature, that the follicular fluid temperature drops during the aspiration procedure, this work aims to evaluate the influence of a pre warming of the aspiration needle as a new protocol.
Detailed description
The estimated sample was 600 oocytes for each group, totaling a minimum of 1200 oocytes, considering a fertilization rate of 65% in the control group and 73% in the study group, for a power of 80% and p alpha 5%, i.e. , an increase of more than 10% between groups. As there is no data in the literature, when the investigators have this sample an interim analysis to evaluate the data will be performed. The investigators consider 10% a reasonable difference that can (with this sample size) increase by 48 embryos and a possible increase of 7 pregnancies within this sample. Bearing in mind that the average number of oocytes retrieved per patient is 6 oocytes, the investigators estimate that 200 patients will be needed to reach the calculated sample number.
The warm-up protocol will be applied by the embryologists, which consists of heating the follicular aspiration needle to 37 Celsius, overnight, the day before the day of the ovarian aspiration procedure.
The variables that will be compared between the studied groups are the rates of oocyte retrieval, maturity (MII), fracture, atresia, fertilization rates and discarded embryos.
Continuous variables will be analyzed using Student's t test if they have normal distribution, for comparison of means between two independent groups or the Wilcoxon-Mann-Whitney U test if not parametric. Differences between groups will be considered significant when p<0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard protocol | No intervention | –The standard protocol comprises no heating of the aspiration needle. |
| Warming protocol | Experimental | Other: warming of the follicular aspiration needleThe aspiration needle will be warm-up overnight the day before the oocyte pick-up procedure |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All women submitted to IVF cycles
Key exclusion criteria (4 listed)
- Women submitted to follicular aspiration due to oocyte cryopreservation
- Patients without oocyte retrieved
- Patients without mature oocyte retrieved
- Procedures with needle replacement
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 |
|---|---|---|
| warming of the follicular aspiration needlethe follicular aspiration needle will be heated overnight before the ovarian aspiration procedure. | Other | Warming protocol |
Primary outcome
normal fertilization rate
Time frame: 16 to 18 hours after fertilization procedure
Fertilization will be confirmed through the visualization of the presence of two pronuclei
4 secondary outcomes
number of oocyte retrieved
Time frame: immediately after ovarian aspiration procedure
number of mature oocyte
Time frame: 3 hours post ovarian aspiration
oocyte damage rate
Time frame: 3 hours post ovarian aspiration
abnormal fertilization rate
Time frame: 16 to 18 hours after fertilization procedure
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 12 Mar 2024.
- 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.
João da 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 warming of the follicular aspiration needle 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 1 inclusion and 4 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 12 Mar 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?
normal fertilization rate (time frame: 16 to 18 hours after fertilization procedure). 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 12 Mar 2024.