Study Stopped
After an interim analysis, it was decided to discontinue the study after a stochastic curtailment analysis.
Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated IVF Cycles
AMOS
1 other identifier
observational
40
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2017
CompletedStudy Start
First participant enrolled
April 21, 2017
CompletedFirst Posted
Study publicly available on registry
April 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2020
CompletedJuly 23, 2020
July 1, 2020
3 years
April 10, 2017
July 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (2)
Incidence of embryo aneuploidies in two cohorts of embryos.
30 days
Morphokinetic evaluation of embryos in two different cohorts of embryos.
30 days
Study Arms (2)
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.
Eligibility Criteria
Women undergoing In Vitro Fertilization treatment
You may qualify if:
- Women
- years old (inclusive)
- with regular menstrual cycles (25-35 days)
- AntiMülleriana Hormone \>5 pmol/L.
- Undergoing IVF treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
IVI Valencia
Valencia, 46003, Spain
Instituto Valenciano de Infertilidad Spain
Valencia, 46015, Spain
IVI Valencia
Valencia, 46015, Spain
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2017
First Posted
April 25, 2017
Study Start
April 21, 2017
Primary Completion
April 7, 2020
Study Completion
July 3, 2020
Last Updated
July 23, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share