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

NCT ID: NCT03128580

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-21

Study Completion Date

2020-07-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Euploid Embryos

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Natural Cycle

The patient will not undergo hyperstimulation rather a natural cycle

No interventions assigned to this group

Stimulated Cycle

The 80 patients will undergo hyperstimulation cycle as per the clinical practice planned for the patient.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IVI Valencia

Valencia, , Spain

Site Status

Instituto Valenciano de Infertilidad Spain

Valencia, , Spain

Site Status

IVI Valencia

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1703-VLC-021-EL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.