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

Terminated

• Conditions: Euploid Embryos

• Registration Number: NCT03128580
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-20
• Study Start: 2017-04-21
• Study First Posted: 2017-04-25
• Primary Completion: 2020-04-07
• Status Verified: 2020-07
• Study Completion: 2020-07-03
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the number of euploid embryos from Metaphase II oocytes in different cohorts of embryos.	30 days	Number of metaphase II oocyte per euploid embryo in unstimulated and stimulated cycles.

Secondary Outcome Measures

Name	Time	Method
Incidence of embryo aneuploidies in two cohorts of embryos.	30 days	Incidence of embryo aneuploidies between the unstimulated and stimulated cycle in the same patient
Morphokinetic evaluation of embryos in two different cohorts of embryos.	30 days	Morphokinetic evaluation of the embryos obtained in an unstimulated and stimulated cycle

Trial Locations

Locations (2)

IVI Valencia; 🇪🇸 Valencia, Spain

Instituto Valenciano de Infertilidad Spain; 🇪🇸 Valencia, Spain