Establish the Amount of CENPV Protein in Human Oocytes as a Diagnostic Tool Against Damage Caused by Ageing or by the Procedure of Vitrification of OocytesCENP-PILOTNCT06788379
CENP-V as a Potential Diagnostic Marker of Damage in Human Oocytes
An observational study of Establish the Amount of CENPV Protein in Human Oocytes as a Diagnostic Tool Against Damage Caused by Ageing or by the Procedure of Vitrification of Oocytes and Advance Maternal Age, run by Vida Recoletas Sevilla at 1 site in Spain.
Trial summary
Proper chromosome segregation is essential to avoid aneuploidy, yet in mammalian oocytes it progressively fails in an age-dependent manner. The ageing population and the increasing age of parenthood are leading to a declined fertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Establish the Amount of CENPV Protein in Human Oocytes as a Diagnostic Tool Against Damage Caused by Ageing or by the Procedure of Vitrification of Oocytes, Advance Maternal Age, Vitrification and Thawing
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 4 Oct 2024to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Adult
Study population: The reference population will be constituted of patients and donors with immature oocytes(GV, MI), obtained after oocyte collection, and mature oocytes (MII) vitrified from patients who decide not to use them and are willing to donate them to research projects. Women willing to participate in this study will be previously informed and will have to sign the informed consent form of the study. The recruitment of patients will be performed in IVI RMA Seville clinic.
Who may be able to join
- Group of patients with advanced maternal age (AMA): patients aged 36-45 years with AMA etiology as the main factor of infertility undergoing controlled ovarian stimulation.
- Group of patients with vitrification / thawing of their oocytes: patients between 18-45 years of age who underwent oocyte vitrification to later, in the study cycle, thaw their oocytes. In this group we contemplate two subgroups:
- Patients with vitrified / thawed oocytes and AMA: between 36-45 years at the moment of oocytes vitrification.
- Patients with vitrified / thawed oocytes and non-AMA: between 18-35 years at the moment of oocytes vitrification.
- Group of control patients: patients and donors with normal etiology, aged 18-35 years, undergoing controlled ovarian stimulation and collection procedures.
Who cannot join
- Patients with pathologies affecting the oocyte quality (PCO, POI, endometriosis, oncology patients, etc.).
- Patients/donors with oocyte cryopreserved by slow freezing technique.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Vida Recoletas Sevilla S.L.
Seville, SEVILLA, 41009
ESTHER SANTAMARÍA LÓPEZ, +34954286274, esther.santamaria@gruporecoletas.com
About this study
Proper chromosome segregation is essential to avoid aneuploidy, yet in mammalian oocytes it progressively fails in an age-dependent manner. The ageing population and the increasing age of parenthood are leading to a declined fertility. Proteins contributing to correct chromosome segregation and oocyte ageing are therefore of central interest. Mouse oocytes deficient in CENP-V are strongly impaired in meiosis I. The spindle assembly checkpoint (SAC)-dependent arrest of about half of the Cenp-V -/- oocytes at metaphase I is only found in oocytes from young adults, not in oocytes >12 months. This suggests SAC weakening in ageing oocytes allowing them to proceed despite continuous presence of mis-aligned chromosomes and present CENP-V depleted oocytes as a model for age dependent weakening of the SAC. Sporadic cases of very-low oocyte survival rate have been observed after vitrification and thawing protocols in the clinical practice. However, no diagnostic tools are currently available to detect these cases. The relevance of this problem has led to a demand on the scientific community to obtain specific and early biomarkers to predict decreased oocyte survival rates after thawing. The main goal of this project is to establish the expression levels of the CENP-V protein in human oocytes as a diagnostic tool for the aging of a cohort of oocytes. With this purpose, the immature oocytes from the oocytes cohort recovered from women with advanced maternal age (AMA) and control, will be matured in vitro in order to compare the CENP-V expression levels between both populations. In addition, in patients with AMA, these expression levels will be correlated with the aneuploidy rate from the blastocyst of the same oocyte cohort. CENP-V-deleted mouse oocytes show higher rate of aneuploidy and spindle aberrations after cold treatment compared to control oocytes. We hypothesize that alterations in the expression level of CENP-V could be responsible of the decrease in oocyte survival rate after thawing. The main objective of this project is to establish the expression levels of the CENP-V protein in human oocytes as a diagnostic tool to assess the damage of a cohort of oocytes. For this purpose, oocytes retrieved from advanced maternal age (AMA) and control patients, as well as oocytes undergoing vitrification / thawing procedures and controls oocytes, will be analyzed. In this study, only the immature oocytes of the patients, which are destined to be discarded and not used in their treatment, will be analyzed.
Read the detailed description
This is a prospective, unicentric, descriptive and transversal study. The main objective of this project is to establish the expression levels of the CENP-V protein in human oocytes as a diagnostic tool of damage in a cohort of human oocytes. With this purpose, CENP-V levels of discarded oocytes retrieved from Advanced Maternal Age (AMA) and control patients will be analyzed in fresh state and after vitrification-thawing procedures. As mature oocytes will be used for the patient's treatment, only immature oocytes, that would otherwise have been discarded, or mature oocyte donated to research, will be used in this project.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced maternal age (AMA) | Patients aged 36-45 years with AMA etiology as the main factor of infertility undergoing controlled ovarian stimulation | |
| Control patients | Patients and donors with normal etiology, aged 18-35 years, undergoing controlled ovarian stimulation and collection procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CENP-V levels y distribution in oocyte
Measured: From enrollment to oocyte retrieval, two days
Secondary outcomes (1)
Survival rate of the oocyte cohort
Measured: From enrollment to oocyte retrieval, two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start4 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Establish the Amount of CENPV Protein in Human Oocytes as a Diagnostic Tool Against Damage Caused by Ageing or by the Procedure of Vitrification of OocytesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- University of Seville
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788379
- Sponsor's protocol ID
- 2012-SEV-102-MF
- Acronym
- CENP-PILOT
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CENP-V as a Potential Diagnostic Marker of Damage in Human Oocytes
- ClinicalTrials.gov ID
- NCT06788379
- Acronym / sponsor ID
- CENP-PILOT / 2012-SEV-102-MF
- Conditions
- Establish the Amount of CENPV Protein in Human Oocytes as a Diagnostic Tool Against Damage Caused by Ageing or by the Procedure of Vitrification of Oocytes, Advance Maternal Age, Vitrification and Thawing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Collaborators
- University of Seville
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jan 2025 (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.
Proper chromosome segregation is essential to avoid aneuploidy, yet in mammalian oocytes it progressively fails in an age-dependent manner. The ageing population and the increasing age of parenthood are leading to a declined fertility. Proteins contributing to correct chromosome segregation and oocyte ageing are therefore of central interest. Mouse oocytes deficient in CENP-V are strongly impaired in meiosis I. The spindle assembly checkpoint (SAC)-dependent arrest of about half of the Cenp-V -/- oocytes at metaphase I is only found in oocytes from young adults, not in oocytes >12 months. This suggests SAC weakening in ageing oocytes allowing them to proceed despite continuous presence of mis-aligned chromosomes and present CENP-V depleted oocytes as a model for age dependent weakening of the SAC. Sporadic cases of very-low oocyte survival rate have been observed after vitrification and thawing protocols in the clinical practice. However, no diagnostic tools are currently available to detect these cases. The relevance of this problem has led to a demand on the scientific community to obtain specific and early biomarkers to predict decreased oocyte survival rates after thawing. The main goal of this project is to establish the expression levels of the CENP-V protein in human oocytes as a diagnostic tool for the aging of a cohort of oocytes. With this purpose, the immature oocytes from the oocytes cohort recovered from women with advanced maternal age (AMA) and control, will be matured in vitro in order to compare the CENP-V expression levels between both populations. In addition, in patients with AMA, these expression levels will be correlated with the aneuploidy rate from the blastocyst of the same oocyte cohort. CENP-V-deleted mouse oocytes show higher rate of aneuploidy and spindle aberrations after cold treatment compared to control oocytes. We hypothesize that alterations in the expression level of CENP-V could be responsible of the decrease in oocyte survival rate after thawing. The main objective of this project is to establish the expression levels of the CENP-V protein in human oocytes as a diagnostic tool to assess the damage of a cohort of oocytes. For this purpose, oocytes retrieved from advanced maternal age (AMA) and control patients, as well as oocytes undergoing vitrification / thawing procedures and controls oocytes, will be analyzed. In this study, only the immature oocytes of the patients, which are destined to be discarded and not used in their treatment, will be analyzed.
Detailed description
This is a prospective, unicentric, descriptive and transversal study. The main objective of this project is to establish the expression levels of the CENP-V protein in human oocytes as a diagnostic tool of damage in a cohort of human oocytes. With this purpose, CENP-V levels of discarded oocytes retrieved from Advanced Maternal Age (AMA) and control patients will be analyzed in fresh state and after vitrification-thawing procedures. As mature oocytes will be used for the patient's treatment, only immature oocytes, that would otherwise have been discarded, or mature oocyte donated to research, will be used in this project.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced maternal age (AMA) | – | –Patients aged 36-45 years with AMA etiology as the main factor of infertility undergoing controlled ovarian stimulation |
| Control patients | – | –Patients and donors with normal etiology, aged 18-35 years, undergoing controlled ovarian stimulation and collection procedures. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The reference population will be constituted of patients and donors with immature oocytes(GV, MI), obtained after oocyte collection, and mature oocytes (MII) vitrified from patients who decide not to use them and are willing to donate them to research projects. Women willing to participate in this study will be previously informed and will have to sign the informed consent form of the study. The recruitment of patients will be performed in IVI RMA Seville clinic.
Key inclusion criteria (5 listed)
- Group of patients with advanced maternal age (AMA): patients aged 36-45 years with AMA etiology as the main factor of infertility undergoing controlled ovarian stimulation.
- Group of patients with vitrification / thawing of their oocytes: patients between 18-45 years of age who underwent oocyte vitrification to later, in the study cycle, thaw their oocytes. In this group we contemplate two subgroups:
- Group of control patients: patients and donors with normal etiology, aged 18-35 years, undergoing controlled ovarian stimulation and collection procedures.
Key exclusion criteria (2 listed)
- Patients with pathologies affecting the oocyte quality (PCO, POI, endometriosis, oncology patients, etc.).
- Patients/donors with oocyte cryopreserved by slow freezing technique.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CENP-V levels y distribution in oocyte
Time frame: From enrollment to oocyte retrieval, two days
1 secondary outcome
Survival rate of the oocyte cohort
Time frame: From enrollment to oocyte retrieval, two days
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 15 Sep 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Establish the Amount of CENPV Protein in Human Oocytes as a Diagnostic Tool Against Damage Caused by Ageing or by the Procedure of Vitrification of Oocytes and Advance Maternal Age, run by Vida Recoletas Sevilla at 1 site in Spain.
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 5 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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 Spain. 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?
Contact ESTHER SANTAMARÍA LÓPEZ (+34954286274, esther.santamaria@gruporecoletas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CENP-V levels y distribution in oocyte (time frame: From enrollment to oocyte retrieval, two days). 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 15 Sep 2026.