- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03128580
Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated IVF Cycles (AMOS)
July 21, 2020 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA
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.
Study Overview
Status
Terminated
Conditions
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 Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Valencia, Spain, 46015
- IVI Valencia
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Valencia, Spain, 46015
- Instituto Valenciano de Infertilidad Spain
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Valencia, Spain, 46003
- IVI Valencia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 38 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Women undergoing In Vitro Fertilization treatment
Description
Inclusion Criteria:
- Women
- 30-38 years old (inclusive)
- with regular menstrual cycles (25-35 days)
- AntiMülleriana Hormone >5 pmol/L.
- Undergoing IVF treatment
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Natural Cycle
The patient will not undergo hyperstimulation rather a natural cycle
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Stimulated Cycle
The 80 patients will undergo hyperstimulation cycle as per the clinical practice planned for the patient.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the number of euploid embryos from Metaphase II oocytes in different cohorts of embryos.
Time Frame: 30 days
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Number of metaphase II oocyte per euploid embryo in unstimulated and stimulated cycles.
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of embryo aneuploidies in two cohorts of embryos.
Time Frame: 30 days
|
Incidence of embryo aneuploidies between the unstimulated and stimulated cycle in the same patient
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30 days
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Morphokinetic evaluation of embryos in two different cohorts of embryos.
Time Frame: 30 days
|
Morphokinetic evaluation of the embryos obtained in an unstimulated and stimulated cycle
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30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2017
Primary Completion (Actual)
April 7, 2020
Study Completion (Actual)
July 3, 2020
Study Registration Dates
First Submitted
April 10, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (Actual)
April 25, 2017
Study Record Updates
Last Update Posted (Actual)
July 23, 2020
Last Update Submitted That Met QC Criteria
July 21, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1703-VLC-021-EL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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