NCT05723016

Brief Summary

The goal of this observational study is to determine is there an association between the rates of aneuploidy and the different ranges of serum Antimullerian hormone (AMH) levels. Retrospective, single-centre study of patients undergoing IVF and preimplantation genetic testing with aneuploidy at the blastocyst stage between January 2018 and December 2022.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

5 years

First QC Date

February 1, 2023

Last Update Submit

February 1, 2023

Conditions

Keywords

AMHIVFAneuploidyPGT-aanti-mullerian hormoneoocyte quality

Outcome Measures

Primary Outcomes (1)

  • Aneuplody rate

    4 years

Secondary Outcomes (2)

  • Clinical pregnancy rate

    4 years

  • Miscarriage rate

    4 years

Study Arms (6)

AMH < 0.5 ng/ml

Other: preimplantation genetic test for aneuploidies (PGT-a)

AMH 0.5-0.99 ng/ml

Other: preimplantation genetic test for aneuploidies (PGT-a)

AMH 1.0-1.49 ng/ml

Other: preimplantation genetic test for aneuploidies (PGT-a)

AMH 1.5-1.99 ng/ml

Other: preimplantation genetic test for aneuploidies (PGT-a)

AMH 2.0-4.99 ng/ml

Other: preimplantation genetic test for aneuploidies (PGT-a)

AMH > 5.0 ng/ml

Other: preimplantation genetic test for aneuploidies (PGT-a)

Interventions

preimplantation genetic test for embryo aneuploidies after IVF

AMH 0.5-0.99 ng/mlAMH 1.0-1.49 ng/mlAMH 1.5-1.99 ng/mlAMH 2.0-4.99 ng/mlAMH < 0.5 ng/mlAMH > 5.0 ng/ml

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent a first IVF cycle with PGT-A at the blastocyst stage

You may qualify if:

  • All started cycles planned to be followed by preimplantation genetic testing for aneuploidies (PGT-A). PGT-A is proposed to the couples for the following reasons: advanced maternal age, recurrent miscarriage, repeated implantation failure or severe male infertility factor; it is also offered to all patients with a good prognosis who desired information regarding the ploidy status of their embryos.

You may not qualify if:

  • Data from oocyte donation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica de la Mujer Medicina Reproductiva

Viña del Mar, Región de Valparaíso, 2520187, Chile

Location

MeSH Terms

Conditions

InfertilityAneuploidy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesChromosome AberrationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations