Anti-Müllerian Hormone and Embryo Aneuploidy

February 1, 2023 updated by: Jose Antonio Moreno, Clinica de la Mujer Medicina Reproductiva, Chile

Serum Anti-Müllerian Hormone Levels and Its Association With Aneuploidy Rates in Human Blastocysts

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  • Data from oocyte donation cycles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AMH < 0.5 ng/ml
Other: preimplantation genetic test for aneuploidies (PGT-a)
preimplantation genetic test for embryo aneuploidies after IVF
AMH 0.5-0.99 ng/ml
Other: preimplantation genetic test for aneuploidies (PGT-a)
preimplantation genetic test for embryo aneuploidies after IVF
AMH 1.0-1.49 ng/ml
Other: preimplantation genetic test for aneuploidies (PGT-a)
preimplantation genetic test for embryo aneuploidies after IVF
AMH 1.5-1.99 ng/ml
Other: preimplantation genetic test for aneuploidies (PGT-a)
preimplantation genetic test for embryo aneuploidies after IVF
AMH 2.0-4.99 ng/ml
Other: preimplantation genetic test for aneuploidies (PGT-a)
preimplantation genetic test for embryo aneuploidies after IVF
AMH > 5.0 ng/ml
Other: preimplantation genetic test for aneuploidies (PGT-a)
preimplantation genetic test for embryo aneuploidies after IVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aneuplody rate
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 4 years
4 years
Miscarriage rate
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica de la Mujer Medicina Reproductiva, Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMH 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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