InfertilitySMARTNCT06539585
Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality
A study testing Meiotic spindle status observation in polarized light and ICSI in people with Infertility and Infertility, Male, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The assisted reproduction success rate is affected by several factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Imaging of the meiotic spindle may be crucial for determining the oocyte maturation and the optimal time of oocyte fertilization by intracytoplasmic sperm… Read more about this study
- Who is it for?
- Ages 35 to 40 years, women only
- Conditions the study is for
- Infertility, Infertility, Male, Infertility, Female
- What is being tested?
- Meiotic spindle status observation in polarized light and ICSI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Jul 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who underwent ICSI;
- Spermiogram containing at least 0.5 mil/ml sperms;
- Morphlogy: normal morphology >1%;
- Stimulated cycles
Who cannot join
- Age under 35 years or over 40;
- Native cycles;
- Severe uterine abnormalities (submucosal fibroid, fibroid ≥5cm, uterine septum, endometrial polyps, uterus duplex)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality (SMART Study)
The assisted reproduction success rate is affected by several factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Imaging of the meiotic spindle may be crucial for determining the oocyte maturation and the optimal time of oocyte fertilization by intracytoplasmic sperm injection (ICSI). A new accurate and non-invasive method for selecting quality maturated oocytes based on meiotic spindle imaging is for women over 35 years of age will be introduced. The evaluation of efficiency using meiotic spindle visibility in polarized light and its relative position to the polar body as indicator of oocyte maturity will be monitored and the optimal time for ICSI will be defined.
Read the detailed description
One of the main strategies of infertility treatment is in vitro fertilization (IVF) . The IVF success rate is affected by several key factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Several authors have suggested that the presence, position and retardance of the optically birefringent meiotic spindle (MS) are related to oocyte developmental competence, affecting the quality of fertilization and embryo development. Oocytes with normal spindle morphology are significantly more likely to produce euploid embryos compared with oocytes with meiotic spindles that are not visible or abnormal. Adjusting the timing of intracytoplasmic sperm injection (ICSI) based on MS morphology has also been proposed. It was shown that adjusting the time of ICSI based on the position of the MS with respect to the polar body (PB) increases the probability of successful fertilization for women over 35 years of age. For the oocytes of patients over 35 years of age, the longer incubation time enabled a greater number of oocytes to become fully mature (MII phase) and prepared for ICSI. In this situation, the MS status was an important indicator of oocyte immaturity.
Patient will be randomized into three groups using Research Electronic Data Capture (REDCap): group 1, standard ICSI without MS imaging; group 2, MS imaging followed by standard ICSI, group 3, MS imaging and ICSI fertilization according MS status. Oocytes from group 3 patients with MS evaluation will be fertilized according to MS status either 5-6 hours after ovum pick-up (OPU) or 7-8 hours after OPU. Oocytes without MS evaluation will all fertilized 5-6 hours after OPU. MS evaluation will take place in pre-prepared glass-bottomed dishes with about 5μl medium with the HEPES buffer covered with paraffin oil, put to heat one hour before use. The oocyte will be rotated using a needle so that Polar Body (PB) and MS are both well visible, and photographs will be taken using optical microscope. The MS status and the angle (α) between MS and PB will be obtained 3-4 hours after oocyte pick-up (OPU). At the same time, the polarized-light microscopy image will be acquired (polarized light microscopy at ×100 magnification. Specially, for oocytes from group 3 patients with PB/MS in close proximity (angle between PB and MS < 5◦) or MS not visible will be predicted as immature oocytes. For these oocytes, ICSI will be performed 4-5 h after the polarization microscopy evaluation, i.e., 7-8 h after OPU. For oocytes with MS clearly visible and PB/MS not in close proximity (angle between PB and MS > 5◦) ICSI will be performed typically 2-3 h after the polarization microscopy evaluation, i.e., 5-6 h after OPU, as for patients from 1 and 2 groups. ICSI will be performed according to standard protocol using ICSI/holding micropipettes (Microtech IVF, Czech Republic), polyvinylpyrrolidone (ICSI™, Vitrolife, Sweden), and Eppendorf (Hamburg, Germany) micromanipulation system equipped with thermoplate (Tokaohit, Japan). The oocytes will be cultivated individually, and their order preserved, so that the other outcomes (data from timelapse, clinical results) can be associated with individual oocytes. We will also monitor the time from the human chorionic gonadotropin (hCG) administration to the completion of the actual fertilization. The oocytes will be denuded (HYASE-10X™, Vitrolife, Sweden) after OPU, and the maturation stage will be examined. Germinal Vesicle (GV) stage oocyte will not be included. Oocytes and embryos in time-lapse incubator from the Japanese manufacturer Astec will be cultivated in a timelapse dish Origio, Denmark Sage 1-Step™, Origio, Denmark under paraffin oil (OVOIL™, VITROLIFE, Sweden) at 37.0 °C, 6% CO2 and 5%O2. Fertilization after ICSI will be defined as the presence of two pronuclei and 2 polar body 16-20 h post ICSI. Embryos will be cultivated for 122-144 h.
Pilot findings will be confirmed in a randomized control trial, i.e. to the efficiency of using MS visibility and relative position to the polar body as indicators of oocyte maturation in order to optimize ICSI timing will be evaluated.
- Conditions
- Infertility, Infertility, Male, Infertility, Female
- Being tested
- Meiotic spindle status observation in polarized light, ICSI
- Keywords
- infertility, human oocyte, IVF, meiotic spindle, ICSI, sperm count
- Medical subject headings
- Infertility, Infertility, Male, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meiotic spindle status observation in polarized lightProcedure or surgery
In patients older than 35 years and younger than 40 years, we will use a microscope with a polarizing filter to evaluate the position of meiotic spindles and polar bodies in oocytes collected from patients who were indicated for IVF and ICSI. Using an optical microscope with a Nikon CEE GmbH polarizing filter, the angle between PB and MS together with MS visibility will be determined.
ICSIProcedure or surgery
ICSI will be performed according to standard protocol using ICSI/holding micropipettes (#002-5-30/#001-120-30, Microtech IVF, Czech Republic), polyvinylpyrrolidone (ICSI™, Vitrolife, Sweden), and Eppendorf (Hamburg, Germany) micromanipulation system equipped with thermoplate (Tokaohit, Japan). The oocytes will be cultivated individually, and their order preserved, so that the other outcomes (data from timelapse, clinical results) can be associated with individual oocytes. Oocytes will be denuded (HYASE-10X™, Vitrolife, Sweden) after OPU, and the maturation stage will be examined.
| Study group | Role | What they receive |
|---|---|---|
| Standard ICSI without meiotic spindle imaging. | Active comparator | A control group of patients who underwent a standard IVF cycle without microscopy of the meiotic spindle. In this control group of patients, ICSI fertilization will be performed 5-6 hours after oocyte collection.
ICSI will be performed according to standard protocol [6]. The oocytes will be cultivated individually, and their order preserved, so that the other outcomes (data from timelapse, clinical results) can be associated with individual oocytes. Fertilization after ICSI will be defined as the presence of two pronuclei and 2 polar body. Embryos will be cultivated for 122-144 h. Receives: Procedure: ICSI |
| Meiotic spindle imaging followed by standard ICSI. | Active comparator | MS evaluation will take place in pre-prepared glass-bottomed dishes with about 5μl medium with the HEPES buffer covered with paraffin oil, put to heat one hour before use. The oocyte will be rotated using a needle so that PB and MS are both well visible, and photographs will be taken using optical microscope. The MS status and the angle (α) between MS and PB will be obtained 3-4 hours after oocyte pick-up (OPU). At the same time, the polarized-light microscopy image will be acquired (polarized light microscopy at ×100 magnification. ICSI will be performed typically 2-3 h after the polarization microscopy evaluation, i.e., 5-6 h after OPU.
ICSI will be performed according to standard protocol [6]. Fertilization after ICSI will be defined as the presence of two pronuclei and 2 polar body. Embryos will be cultivated for 122-144 h. Receives: Procedure: Meiotic spindle status observation in polarized light; Procedure: ICSI |
| MS imaging and ICSI fertilization according MS status. | Active comparator | Oocytes with MS evaluation will be fertilized according to MS status either 5-6 hours after ovum pick-up (OPU) or 7-8 hours after OPU. MS evaluation will take place in pre-prepared glass-bottomed dishes. The MS status and the angle (α) between MS and PB will be obtained 3-4 hours after oocyte pick-up (OPU). At the same time, the polarized-light microscopy image will be acquired (polarized light microscopy at ×100 magnification. For oocytes with PB/MS in close proximity (angle between PB and MS < 5◦) or MS not visible ICSI will be performed 4-5 h after the polarization microscopy evaluation, i.e., 7-8 h after OPU (these oocytes are supposed to be not fully mature). For oocytes with MS clearly visible and PB/MS not in close proximity (angle between PB and MS > 5◦) ICSI will be performed typically 2-3 h after the polarization microscopy evaluation, i.e., 5-6 h after OPU.
ICSI will be performed according to standard protocol [6]. Receives: Procedure: Meiotic spindle status observation in polarized light; Procedure: ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate of patients whose ICSI time was established according to MS state
The percentage of all attempts that leads to pregnancy of patients whose ICSI fertilization was done according MS status. Meiotic spindle visibility in polarized light and its relative position to the polar body as indicator of oocyte maturity will be monitored and the optimal time for ICSI will be defined.
Measured: 6-8 weeks
Secondary outcomes (1)
clinical pregnancy rate of patients whose ICSI time was not established according to measured MS state
The percentage of all attempts that leads to pregnancy of patients whose ICSI fertilization was not done according MS status. But the meiotic spindle visibility in polarized light and its relative position to the polar body was measured.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start18 Jul 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Czech Academy of Sciences, Czech Technical University in Prague, General University Hospital, Prague
- Responsible party
- Principal investigator, Jaromír Mašata, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539585
- Sponsor's protocol ID
- MW24-08-00048
- Acronym
- SMART
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Loendersloot LL, van Wely M, Limpens J, Bossuyt PM, Repping S, van der Veen F. Predictive factors in in vitro fertilization (IVF): a systematic review and meta-analysis. Hum Reprod Update. 2010 Nov-Dec;16(6):577-89. doi: 10.1093/humupd/dmq015. Epub 2010 Jun 25.
PubMed 20581128Wu B, Shi J, Zhao W, Lu S, Silva M, Gelety TJ. Understanding reproducibility of human IVF traits to predict next IVF cycle outcome. J Assist Reprod Genet. 2014 Oct;31(10):1323-30. doi: 10.1007/s10815-014-0288-y. Epub 2014 Aug 15.
PubMed 25119191Hanevik HI, Hessen DO. IVF and human evolution. Hum Reprod Update. 2022 Jun 30;28(4):457-479. doi: 10.1093/humupd/dmac014.
PubMed 35355060Rienzi L, Ubaldi F, Martinez F, Iacobelli M, Minasi MG, Ferrero S, Tesarik J, Greco E. Relationship between meiotic spindle location with regard to the polar body position and oocyte developmental potential after ICSI. Hum Reprod. 2003 Jun;18(6):1289-93. doi: 10.1093/humrep/deg274.
PubMed 12773461Innocenti F, Fiorentino G, Cimadomo D, Soscia D, Garagna S, Rienzi L, Ubaldi FM, Zuccotti M; SIERR. Maternal effect factors that contribute to oocytes developmental competence: an update. J Assist Reprod Genet. 2022 Apr;39(4):861-871. doi: 10.1007/s10815-022-02434-y. Epub 2022 Feb 15.
PubMed 35165782Rienzi L, Vajta G, Ubaldi F. Predictive value of oocyte morphology in human IVF: a systematic review of the literature. Hum Reprod Update. 2011 Jan-Feb;17(1):34-45. doi: 10.1093/humupd/dmq029. Epub 2010 Jul 16.
PubMed 20639518Tepla O, Topurko Z, Jirsova S, Moosova M, Fajmonova E, Cabela R, Komrskova K, Kratochvilova I, Masata J. Timing of ICSI with Respect to Meiotic Spindle Status. Int J Mol Sci. 2022 Dec 21;24(1):105. doi: 10.3390/ijms24010105.
PubMed 36613547
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality (SMART Study)
- ClinicalTrials.gov ID
- NCT06539585
- Acronym / sponsor ID
- SMART / MW24-08-00048
- Conditions
- Infertility, Infertility, Male, Infertility, Female
- Keywords
- infertility, human oocyte, IVF, meiotic spindle, ICSI, sperm count
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Czech Academy of Sciences, Czech Technical University in Prague, General University Hospital, Prague
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 6 Aug 2024 (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 assisted reproduction success rate is affected by several factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Imaging of the meiotic spindle may be crucial for determining the oocyte maturation and the optimal time of oocyte fertilization by intracytoplasmic sperm injection (ICSI). A new accurate and non-invasive method for selecting quality maturated oocytes based on meiotic spindle imaging is for women over 35 years of age will be introduced. The evaluation of efficiency using meiotic spindle visibility in polarized light and its relative position to the polar body as indicator of oocyte maturity will be monitored and the optimal time for ICSI will be defined.
Detailed description
One of the main strategies of infertility treatment is in vitro fertilization (IVF) . The IVF success rate is affected by several key factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Several authors have suggested that the presence, position and retardance of the optically birefringent meiotic spindle (MS) are related to oocyte developmental competence, affecting the quality of fertilization and embryo development. Oocytes with normal spindle morphology are significantly more likely to produce euploid embryos compared with oocytes with meiotic spindles that are not visible or abnormal. Adjusting the timing of intracytoplasmic sperm injection (ICSI) based on MS morphology has also been proposed. It was shown that adjusting the time of ICSI based on the position of the MS with respect to the polar body (PB) increases the probability of successful fertilization for women over 35 years of age. For the oocytes of patients over 35 years of age, the longer incubation time enabled a greater number of oocytes to become fully mature (MII phase) and prepared for ICSI. In this situation, the MS status was an important indicator of oocyte immaturity.
Patient will be randomized into three groups using Research Electronic Data Capture (REDCap): group 1, standard ICSI without MS imaging; group 2, MS imaging followed by standard ICSI, group 3, MS imaging and ICSI fertilization according MS status. Oocytes from group 3 patients with MS evaluation will be fertilized according to MS status either 5-6 hours after ovum pick-up (OPU) or 7-8 hours after OPU. Oocytes without MS evaluation will all fertilized 5-6 hours after OPU. MS evaluation will take place in pre-prepared glass-bottomed dishes with about 5μl medium with the HEPES buffer covered with paraffin oil, put to heat one hour before use. The oocyte will be rotated using a needle so that Polar Body (PB) and MS are both well visible, and photographs will be taken using optical microscope. The MS status and the angle (α) between MS and PB will be obtained 3-4 hours after oocyte pick-up (OPU). At the same time, the polarized-light microscopy image will be acquired (polarized light microscopy at ×100 magnification. Specially, for oocytes from group 3 patients with PB/MS in close proximity (angle between PB and MS < 5◦) or MS not visible will be predicted as immature oocytes. For these oocytes, ICSI will be performed 4-5 h after the polarization microscopy evaluation, i.e., 7-8 h after OPU. For oocytes with MS clearly visible and PB/MS not in close proximity (angle between PB and MS > 5◦) ICSI will be performed typically 2-3 h after the polarization microscopy evaluation, i.e., 5-6 h after OPU, as for patients from 1 and 2 groups. ICSI will be performed according to standard protocol using ICSI/holding micropipettes (Microtech IVF, Czech Republic), polyvinylpyrrolidone (ICSI™, Vitrolife, Sweden), and Eppendorf (Hamburg, Germany) micromanipulation system equipped with thermoplate (Tokaohit, Japan). The oocytes will be cultivated individually, and their order preserved, so that the other outcomes (data from timelapse, clinical results) can be associated with individual oocytes. We will also monitor the time from the human chorionic gonadotropin (hCG) administration to the completion of the actual fertilization. The oocytes will be denuded (HYASE-10X™, Vitrolife, Sweden) after OPU, and the maturation stage will be examined. Germinal Vesicle (GV) stage oocyte will not be included. Oocytes and embryos in time-lapse incubator from the Japanese manufacturer Astec will be cultivated in a timelapse dish Origio, Denmark Sage 1-Step™, Origio, Denmark under paraffin oil (OVOIL™, VITROLIFE, Sweden) at 37.0 °C, 6% CO2 and 5%O2. Fertilization after ICSI will be defined as the presence of two pronuclei and 2 polar body 16-20 h post ICSI. Embryos will be cultivated for 122-144 h.
Pilot findings will be confirmed in a randomized control trial, i.e. to the efficiency of using MS visibility and relative position to the polar body as indicators of oocyte maturation in order to optimize ICSI timing will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard ICSI without meiotic spindle imaging. | Active comparator | Procedure: ICSIA control group of patients who underwent a standard IVF cycle without microscopy of the meiotic spindle. In this control group of patients, ICSI fertilization will be performed 5-6 hours after oocyte collection. ICSI will be performed according to standard protocol [6]. The oocytes will be cultivated individually, and their order preserved, so that the other outcomes (data from timelapse, clinical results) can be associated with individual oocytes. Fertilization after ICSI will be defined as the presence of two pronuclei and 2 polar body. Embryos will be cultivated for 122-144 h. |
| Meiotic spindle imaging followed by standard ICSI. | Active comparator | Procedure: Meiotic spindle status observation in polarized light, Procedure: ICSIMS evaluation will take place in pre-prepared glass-bottomed dishes with about 5μl medium with the HEPES buffer covered with paraffin oil, put to heat one hour before use. The oocyte will be rotated using a needle so that PB and MS are both well visible, and photographs will be taken using optical microscope. The MS status and the angle (α) between MS and PB will be obtained 3-4 hours after oocyte pick-up (OPU). At the same time, the polarized-light microscopy image will be acquired (polarized light microscopy at ×100 magnification. ICSI will be performed typically 2-3 h after the polarization microscopy evaluation, i.e., 5-6 h after OPU. ICSI will be performed according to standard protocol [6]. Fertilization after ICSI will be defined as the presence of two pronuclei and 2 polar body. Embryos will be cultivated for 122-144 h. |
| MS imaging and ICSI fertilization according MS status. | Active comparator | Procedure: Meiotic spindle status observation in polarized light, Procedure: ICSIOocytes with MS evaluation will be fertilized according to MS status either 5-6 hours after ovum pick-up (OPU) or 7-8 hours after OPU. MS evaluation will take place in pre-prepared glass-bottomed dishes. The MS status and the angle (α) between MS and PB will be obtained 3-4 hours after oocyte pick-up (OPU). At the same time, the polarized-light microscopy image will be acquired (polarized light microscopy at ×100 magnification. For oocytes with PB/MS in close proximity (angle between PB and MS < 5◦) or MS not visible ICSI will be performed 4-5 h after the polarization microscopy evaluation, i.e., 7-8 h after OPU (these oocytes are supposed to be not fully mature). For oocytes with MS clearly visible and PB/MS not in close proximity (angle between PB and MS > 5◦) ICSI will be performed typically 2-3 h after the polarization microscopy evaluation, i.e., 5-6 h after OPU. ICSI will be performed according to standard protocol [6]. |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women who underwent ICSI;
- Spermiogram containing at least 0.5 mil/ml sperms;
- Morphlogy: normal morphology >1%;
- Stimulated cycles
Key exclusion criteria (3 listed)
- Age under 35 years or over 40;
- Native cycles;
- Severe uterine abnormalities (submucosal fibroid, fibroid ≥5cm, uterine septum, endometrial polyps, uterus duplex)
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 |
|---|---|---|
| Meiotic spindle status observation in polarized lightIn patients older than 35 years and younger than 40 years, we will use a microscope with a polarizing filter to evaluate the position of meiotic spindles and polar bodies in oocytes collected from patients who were indicated for IVF and ICSI. Using an optical microscope with a Nikon CEE GmbH polarizing filter, the angle between PB and MS together with MS visibility will be determined. | Procedure or surgery | MS imaging and ICSI fertilization according MS status., Meiotic spindle imaging followed by standard ICSI. |
| ICSIICSI will be performed according to standard protocol using ICSI/holding micropipettes (#002-5-30/#001-120-30, Microtech IVF, Czech Republic), polyvinylpyrrolidone (ICSI™, Vitrolife, Sweden), and Eppendorf (Hamburg, Germany) micromanipulation system equipped with thermoplate (Tokaohit, Japan). The oocytes will be cultivated individually, and their order preserved, so that the other outcomes (data from timelapse, clinical results) can be associated with individual oocytes. Oocytes will be denuded (HYASE-10X™, Vitrolife, Sweden) after OPU, and the maturation stage will be examined. | Procedure or surgery | MS imaging and ICSI fertilization according MS status., Meiotic spindle imaging followed by standard ICSI., Standard ICSI without meiotic spindle imaging. |
Primary outcome
Clinical pregnancy rate of patients whose ICSI time was established according to MS state
Time frame: 6-8 weeks
The percentage of all attempts that leads to pregnancy of patients whose ICSI fertilization was done according MS status. Meiotic spindle visibility in polarized light and its relative position to the polar body as indicator of oocyte maturity will be monitored and the optimal time for ICSI will be defined.
1 secondary outcome
clinical pregnancy rate of patients whose ICSI time was not established according to measured MS state
Time frame: 6-8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 20581128van Loendersloot LL, van Wely M, Limpens J, Bossuyt PM, Repping S, van der Veen F. Predictive factors in in vitro fertilization (IVF): a systematic review and meta-analysis. Hum Reprod Update. 2010 Nov-Dec;16(6):577-89. doi: 10.1093/humupd/dmq015. Epub 2010 Jun 25.
- Background: PubMed 25119191Wu B, Shi J, Zhao W, Lu S, Silva M, Gelety TJ. Understanding reproducibility of human IVF traits to predict next IVF cycle outcome. J Assist Reprod Genet. 2014 Oct;31(10):1323-30. doi: 10.1007/s10815-014-0288-y. Epub 2014 Aug 15.
- Background: PubMed 35355060Hanevik HI, Hessen DO. IVF and human evolution. Hum Reprod Update. 2022 Jun 30;28(4):457-479. doi: 10.1093/humupd/dmac014.
- Background: PubMed 12773461Rienzi L, Ubaldi F, Martinez F, Iacobelli M, Minasi MG, Ferrero S, Tesarik J, Greco E. Relationship between meiotic spindle location with regard to the polar body position and oocyte developmental potential after ICSI. Hum Reprod. 2003 Jun;18(6):1289-93. doi: 10.1093/humrep/deg274.
- Background: PubMed 35165782Innocenti F, Fiorentino G, Cimadomo D, Soscia D, Garagna S, Rienzi L, Ubaldi FM, Zuccotti M; SIERR. Maternal effect factors that contribute to oocytes developmental competence: an update. J Assist Reprod Genet. 2022 Apr;39(4):861-871. doi: 10.1007/s10815-022-02434-y. Epub 2022 Feb 15.
- Background: PubMed 20639518Rienzi L, Vajta G, Ubaldi F. Predictive value of oocyte morphology in human IVF: a systematic review of the literature. Hum Reprod Update. 2011 Jan-Feb;17(1):34-45. doi: 10.1093/humupd/dmq029. Epub 2010 Jul 16.
- Results publication: PubMed 36613547Tepla O, Topurko Z, Jirsova S, Moosova M, Fajmonova E, Cabela R, Komrskova K, Kratochvilova I, Masata J. Timing of ICSI with Respect to Meiotic Spindle Status. Int J Mol Sci. 2022 Dec 21;24(1):105. doi: 10.3390/ijms24010105.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meiotic spindle status observation in polarized light and ICSI in people with Infertility and Infertility, Male, run by Charles University, Czech Republic at 1 site in Czechia.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical pregnancy rate of patients whose ICSI time was established according to MS state (time frame: 6-8 weeks). 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 NCT06539585, which also lists 7 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 6 Aug 2024.