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

Euploid Embryos Clinical Trial

— AMOS  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03128580
• Other study ID #: 1703-VLC-021-EL
• Status: Terminated
• Start date: April 21, 2017
• Est. completion date: July 3, 2020

Study information

• Verified date: July 2020
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: July 3, 2020
• Est. primary completion date: April 7, 2020
• Gender: Female
• Age group: 30 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• Euploid Embryos

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad Spain	Valencia
Spain	IVI Valencia	Valencia
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of embryo aneuploidies in two cohorts of embryos.	Incidence of embryo aneuploidies between the unstimulated and stimulated cycle in the same patient	30 days
Secondary	Morphokinetic evaluation of embryos in two different cohorts of embryos.	Morphokinetic evaluation of the embryos obtained in an unstimulated and stimulated cycle	30 days