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Clinical Trials/NCT03128580
NCT03128580
Terminated
Not Applicable

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.

Instituto Valenciano de Infertilidad, IVI VALENCIA2 sites in 1 country40 target enrollmentApril 21, 2017
ConditionsEuploid Embryos

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Euploid Embryos
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Enrollment
40
Locations
2
Primary Endpoint
Comparison of the number of euploid embryos from Metaphase II oocytes in different cohorts of embryos.
Status
Terminated
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 21, 2017
End Date
July 3, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Incidence of embryo aneuploidies in two cohorts of embryos.(30 days)
  • Morphokinetic evaluation of embryos in two different cohorts of embryos.(30 days)

Study Sites (2)

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