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TerminatedNCT03128580AMOSUpdated Jul 23, 2020

Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated IVF Cycles

An observational study in Euploid Embryos, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Terminated at 3 sites in Spain. Open to female participants aged 30 Years to 38 Years. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Observational

Why this study was terminated
After an interim analysis, it was decided to discontinue the study after a stochastic curtailment analysis.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
30 Years to 38 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Euploid Embryos

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03

Who can participate

Ages eligible
30 Years to 38 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Women undergoing In Vitro Fertilization treatment

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: 30 days

Secondary outcomes

  1. Incidence of embryo aneuploidies in two cohorts of embryos.

    Incidence of embryo aneuploidies between the unstimulated and stimulated cycle in the same patient

    Time frame: 30 days

  2. Morphokinetic evaluation of embryos in two different cohorts of embryos.

    Morphokinetic evaluation of the embryos obtained in an unstimulated and stimulated cycle

    Time frame: 30 days

06

Study locations

3 sites
  • IVI Valencia
    Valencia, 46003, Spain
  • Instituto Valenciano de Infertilidad Spain
    Valencia, 46015, Spain
  • IVI Valencia
    Valencia, 46015, Spain
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03128580
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible party
Sponsor
First posted
Apr 25, 2017
Start date
Apr 21, 2017
Primary completion
Apr 7, 2020
Completion
Jul 3, 2020
Last update
Jul 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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