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CompletedNCT05723016Updated Feb 10, 2023

Anti-Müllerian Hormone and Embryo Aneuploidy

An observational study in Infertility and Aneuploidy, sponsored by Clinica de la Mujer Medicina Reproductiva, Chile. Completed at 1 site in Chile. Open to female participants. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Clinica de la Mujer Medicina Reproductiva, Chile · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
300
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility
  • Aneuploidy

Keywords

  • AMH
  • IVF
  • Aneuploidy
  • PGT-a
  • anti-mullerian hormone
  • oocyte quality
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Data from oocyte donation cycles
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Otherpreimplantation genetic test for aneuploidies (PGT-a)

    preimplantation genetic test for embryo aneuploidies after IVF

05

What researchers measure

Primary outcomes

  1. Aneuplody rate

    Time frame: 4 years

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 4 years

  2. Miscarriage rate

    Time frame: 4 years

06

Study locations

1 site
  • Clinica de la Mujer Medicina Reproductiva
    Viña Del Mar, Valparaíso 2520187, Chile
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05723016
Lead sponsor
Clinica de la Mujer Medicina Reproductiva, Chile
Responsible party
Jose Antonio Moreno (MD, PhD, Clinica de la Mujer Medicina Reproductiva, Chile) — Principal investigator
First posted
Feb 10, 2023
Start date
Jan 1, 2018
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Feb 10, 2023

Oversight

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

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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