InfertilityNCT05723016
Anti-Müllerian Hormone and Embryo Aneuploidy
An observational study of Infertility and Aneuploidy, run by Clinica de la Mujer Medicina Reproductiva, Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Aneuploidy
- What is being tested?
- preimplantation genetic test for aneuploidies (PGT-a)
- How many people
- 300 participants
- Where
- 1 siteChile
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent a first IVF cycle with PGT-A at the blastocyst stage
Who may be able to join
- 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.
Who cannot join
- Data from oocyte donation cycles
Trial locations and contacts
1 site in 1 country.
Chile1 site
Clinica de la Mujer Medicina Reproductiva
Viña del Mar, Valparaiso, 2520187
About this study
Official title: 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.
- Conditions
- Infertility, Aneuploidy
- Being tested
- preimplantation genetic test for aneuploidies (PGT-a)
- Keywords
- AMH, IVF, Aneuploidy, PGT-a, anti-mullerian hormone, oocyte quality
- Medical subject headings
- Infertility, Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preimplantation genetic test for aneuploidies (PGT-a)Other
preimplantation genetic test for embryo aneuploidies after IVF
| Study group | Role | What they receive |
|---|---|---|
| AMH < 0.5 ng/ml | Not described Receives: Other: preimplantation genetic test for aneuploidies (PGT-a) | |
| AMH 0.5-0.99 ng/ml | Not described Receives: Other: preimplantation genetic test for aneuploidies (PGT-a) | |
| AMH 1.0-1.49 ng/ml | Not described Receives: Other: preimplantation genetic test for aneuploidies (PGT-a) | |
| AMH 1.5-1.99 ng/ml | Not described Receives: Other: preimplantation genetic test for aneuploidies (PGT-a) | |
| AMH 2.0-4.99 ng/ml | Not described Receives: Other: preimplantation genetic test for aneuploidies (PGT-a) | |
| AMH > 5.0 ng/ml | Not described Receives: Other: preimplantation genetic test for aneuploidies (PGT-a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneuplody rate
Measured: 4 years
Secondary outcomes (2)
Clinical pregnancy rate
Measured: 4 years
Miscarriage rate
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica de la Mujer Medicina Reproductiva, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Antonio Moreno, Clinica de la Mujer Medicina Reproductiva, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723016
- Sponsor's protocol ID
- AMH 2023
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Anti-Müllerian Hormone Levels and Its Association With Aneuploidy Rates in Human Blastocysts
- ClinicalTrials.gov ID
- NCT05723016
- Acronym / sponsor ID
- AMH 2023
- Conditions
- Infertility, Aneuploidy
- Keywords
- AMH, IVF, Aneuploidy, PGT-a, anti-mullerian hormone, oocyte quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Clinica de la Mujer Medicina Reproductiva, ChileUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent a first IVF cycle with PGT-A at the blastocyst stage
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Data from oocyte donation cycles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preimplantation genetic test for aneuploidies (PGT-a)preimplantation genetic test for embryo aneuploidies after IVF | Other | AMH 0.5-0.99 ng/ml, AMH 1.0-1.49 ng/ml, AMH 1.5-1.99 ng/ml, AMH 2.0-4.99 ng/ml, AMH < 0.5 ng/ml, AMH > 5.0 ng/ml |
Primary outcome
Aneuplody rate
Time frame: 4 years
2 secondary outcomes
Clinical pregnancy rate
Time frame: 4 years
Miscarriage rate
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Aneuploidy, run by Clinica de la Mujer Medicina Reproductiva, Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneuplody rate (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.