Euploid EmbryosAMOSNCT03128580
Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated IVF Cycles
An observational study of Euploid Embryos, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 3 sites in Spain.
Trial summary
The purpose of this study is to compare the number of euploid embryos obtained per metaphase II oocyte in unstimulated (modified natural cycles) and stimulated IVF cycles. Read more about this study
- Who is it for?
- Ages 30 to 38 years, women only
- Conditions the study is for
- Euploid Embryos
- How many people
- 40 participants
- Where
- 3 sitesSpain
- Study dates
- 21 Apr 2017to 3 Jul 2020
- 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 30 to 38 years
- Women only
- Adult
Study population: Women undergoing In Vitro Fertilization treatment
Who may be able to join
- Women
- 30-38 years old (inclusive)
- with regular menstrual cycles (25-35 days)
- AntiMülleriana Hormone >5 pmol/L.
- Undergoing IVF treatment
Who cannot join
- BMI >30 kg/m2
- repeated miscarriages
- implantation failure
- uterine or adnexal pathology
- Unable to be treated with gonadotrophins for the ovarian hyperstimulation
- history of low response to ovarian hyperstimulation
- participation in another study with PGS for monogenic pathology
- Cryptozoospermia in male partner
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
IVI Valencia
Valencia, 46003
Instituto Valenciano de Infertilidad Spain
Valencia, 46015
IVI Valencia
Valencia, 46015
About this study
Official title: Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated Cycles. An Intrapatient Comparison Using Next Generation Sequencing in Biopsy of Blastocysts and Time Lapse Evaluation.
The purpose of this study is to compare the number of euploid embryos obtained per metaphase II oocyte in unstimulated (modified natural cycles) and stimulated IVF cycles.
Read the detailed description
Effects of ovarian stimulation on human embryo quality is still a subject of study. When natural and stimulated cycles have been compared, no differences have been observed in terms of embryo cleavage capacity, oocyte and embryo aneuploidy rate or incidence of aneuploidy in aborted foetuses. When mild and conventional doses of gonadotropins have been compared, a higher proportion of good morphological quality embryos are observed in the former. On the contrary, we showed that ovarian stimulation does not increase significantly the embryo aneuploidy rate in IVF derived human embryos when unstimulated and stimulated cycles were compared in oocyte donors. In this study, we want to compare the embryo aneuploidy rate between unstimulated and stimulated cycles in infertile patients, subjected to both IVF cycles with blastocyst biopsy and NGS-PGS. A comparison of the morphokinetics will also be performed.
- Conditions
- Euploid Embryos
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 |
|---|---|---|
| Natural Cycle | The patient will not undergo hyperstimulation rather a natural cycle | |
| Stimulated Cycle | The 80 patients will undergo hyperstimulation cycle as per the clinical practice planned for the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the number of euploid embryos from Metaphase II oocytes in different cohorts of embryos.
Number of metaphase II oocyte per euploid embryo in unstimulated and stimulated cycles.
Measured: 30 days
Secondary outcomes (2)
Incidence of embryo aneuploidies in two cohorts of embryos.
Incidence of embryo aneuploidies between the unstimulated and stimulated cycle in the same patient
Measured: 30 days
Morphokinetic evaluation of embryos in two different cohorts of embryos.
Morphokinetic evaluation of the embryos obtained in an unstimulated and stimulated cycle
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start21 Apr 2017
- Primary completion7 Apr 2020
- Study completion3 Jul 2020
Why it stopped: After an interim analysis, it was decided to discontinue the study after a stochastic curtailment analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Euploid EmbryosStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128580
- Sponsor's protocol ID
- 1703-VLC-021-EL
- Acronym
- AMOS
- Status last verified
- Jul 2020
- First submitted
- 10 Apr 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- 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 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated Cycles. An Intrapatient Comparison Using Next Generation Sequencing in Biopsy of Blastocysts and Time Lapse Evaluation.
- ClinicalTrials.gov ID
- NCT03128580
- Acronym / sponsor ID
- AMOS / 1703-VLC-021-EL
- Conditions
- Euploid Embryos
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: After an interim analysis, it was decided to discontinue the study after a stochastic curtailment analysis.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 25 Apr 2017 (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 purpose of this study is to compare the number of euploid embryos obtained per metaphase II oocyte in unstimulated (modified natural cycles) and stimulated IVF cycles.
Detailed description
Effects of ovarian stimulation on human embryo quality is still a subject of study. When natural and stimulated cycles have been compared, no differences have been observed in terms of embryo cleavage capacity, oocyte and embryo aneuploidy rate or incidence of aneuploidy in aborted foetuses. When mild and conventional doses of gonadotropins have been compared, a higher proportion of good morphological quality embryos are observed in the former. On the contrary, we showed that ovarian stimulation does not increase significantly the embryo aneuploidy rate in IVF derived human embryos when unstimulated and stimulated cycles were compared in oocyte donors. In this study, we want to compare the embryo aneuploidy rate between unstimulated and stimulated cycles in infertile patients, subjected to both IVF cycles with blastocyst biopsy and NGS-PGS. A comparison of the morphokinetics will also be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural Cycle | – | –The patient will not undergo hyperstimulation rather a natural cycle |
| Stimulated Cycle | – | –The 80 patients will undergo hyperstimulation cycle as per the clinical practice planned for the patient. |
Who may qualify
- Ages
- 30 to 38 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women undergoing In Vitro Fertilization treatment
Key inclusion criteria (5 listed)
- Women
- 30-38 years old (inclusive)
- with regular menstrual cycles (25-35 days)
- AntiMülleriana Hormone >5 pmol/L.
- Undergoing IVF treatment
Key exclusion criteria (8 listed)
- BMI >30 kg/m2
- repeated miscarriages
- implantation failure
- uterine or adnexal pathology
- Unable to be treated with gonadotrophins for the ovarian hyperstimulation
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
Comparison of the number of euploid embryos from Metaphase II oocytes in different cohorts of embryos.
Time frame: 30 days
Number of metaphase II oocyte per euploid embryo in unstimulated and stimulated cycles.
2 secondary outcomes
Incidence of embryo aneuploidies in two cohorts of embryos.
Time frame: 30 days
Morphokinetic evaluation of embryos in two different cohorts of embryos.
Time frame: 30 days
Results and safety
The study was stopped early (reason given: After an interim analysis, it was decided to discontinue the study after a stochastic curtailment analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: No
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Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
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INtensity of OVarian Stimualtion and Euploid Embryos
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Non-Euploid Embryo Transfer (NEET) Registry
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Euploid Embryos, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 3 sites 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 8 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: stopped early, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: After an interim analysis, it was decided to discontinue the study after a stochastic curtailment analysis.). Results are not available in the source record.
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?
Comparison of the number of euploid embryos from Metaphase II oocytes in different cohorts of embryos. (time frame: 30 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 23 Jul 2020.