AneuploidyIVMNCT03860064
Aneuploidy Rates of in Vitro Matured Oocytes
An observational study of Aneuploidy, run by IVI Barcelona at 1 site in Spain.
Trial summary
In general, nearly 85% of retrieved oocytes are mature and reproductively useful after the retrieval, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Aneuploidy
- What is being tested?
- Non intervention
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 27 Mar 2019to 30 Sep 2019
- Phase
- Observational
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Mature ooocytes from the same donors, will be used as control group.
Who may be able to join
- 18-35-year-old women
- BMI: >18 and < 30 kg/m2
- Normal female karyotype
- Normal uterus and ovaries at transvaginal ultrasound
Who cannot join
- > 35 years
- PCO syndrome carriers
- Null follicle aspiration
- History of chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
In general, nearly 85% of retrieved oocytes are mature and reproductively useful after the retrieval, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively).
The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.
Read the detailed description
Under controlled ovarian stimulation, patients with normal functional ovarian reserves produce a good number of oocytes at retrieval. However, in addition to quantity, oocyte maturity is an important variable for the success of reproductive technologies. In general, nearly 85% of retrieved oocytes are mature and reproductively useful, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively). Due to the limited expectations held for in vitro maturation in said stimulated cycles, the rescue of immature oocytes is not widely used in current clinical practice and these oocytes are usually discarded due to the possibility of abnormal embryonic development or an increased rate of abortion.
The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.
- Conditions
- Aneuploidy
- Being tested
- Non intervention
- Medical subject headings
- Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionOther
Non
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneuploidy rate
Aneuploidy rate of the PB
Measured: The moment that the PB is extruded (between 1 hour and 50 hours after the denudation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start27 Mar 2019
- Primary completion30 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneuploidyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860064
- Sponsor's protocol ID
- 1810-BCN-071-ME
- Acronym
- IVM
- Status last verified
- Jul 2019
- First submitted
- 27 Feb 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneuploidy Rates of in Vitro Matured Oocytes
- ClinicalTrials.gov ID
- NCT03860064
- Acronym / sponsor ID
- IVM / 1810-BCN-071-ME
- Conditions
- Aneuploidy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IVI BarcelonaUniversity, hospital or other
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 1 Mar 2019 (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.
In general, nearly 85% of retrieved oocytes are mature and reproductively useful after the retrieval, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively).
The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.
Detailed description
Under controlled ovarian stimulation, patients with normal functional ovarian reserves produce a good number of oocytes at retrieval. However, in addition to quantity, oocyte maturity is an important variable for the success of reproductive technologies. In general, nearly 85% of retrieved oocytes are mature and reproductively useful, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively). Due to the limited expectations held for in vitro maturation in said stimulated cycles, the rescue of immature oocytes is not widely used in current clinical practice and these oocytes are usually discarded due to the possibility of abnormal embryonic development or an increased rate of abortion.
The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mature ooocytes from the same donors, will be used as control group.
Key inclusion criteria (4 listed)
- 18-35-year-old women
- BMI: >18 and < 30 kg/m2
- Normal female karyotype
- Normal uterus and ovaries at transvaginal ultrasound
Key exclusion criteria (4 listed)
- > 35 years
- PCO syndrome carriers
- Null follicle aspiration
- History of chemotherapy or radiotherapy
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 |
|---|---|---|
| Non interventionNon | Other | – |
Primary outcome
Aneuploidy rate
Time frame: The moment that the PB is extruded (between 1 hour and 50 hours after the denudation)
Aneuploidy rate of the PB
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 19 Nov 2019.
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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?
An observational study of Aneuploidy, run by IVI Barcelona 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 4 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 19 Nov 2019. 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?
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?
Aneuploidy rate (time frame: The moment that the PB is extruded (between 1 hour and 50 hours after the denudation)). 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 19 Nov 2019.