niPGT-A for Infertility

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Crecer: Centro de Reproducción y Genética Humana, Mar Del Plata, Argentina
Infertility+4 More
niPGT-A - DiagnosticTest
Eligibility
18 - 65
Female
What conditions do you have?
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Study Summary

RCT Study to Validate niPGT-A Clinical Benefit.

See full description

Eligible Conditions

  • Infertility
  • Chromosome Abnormalities
  • Aneuploidy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Infertility

Study Objectives

This trial is evaluating whether niPGT-A will improve 2 primary outcomes and 9 secondary outcomes in patients with Infertility. Measurement will happen over the course of 7 days at least.

7 days
Non-invasive analysis of the chromosomal status of the embryo
7 days at least
NGS results of the SBM
Over 12 weeks
Ongoing pregnancy rate
Over 40 weeks
Live birth rate
Obstetrical outcomes comparison
Month 6
Cumulative live birth rate
Cumulative ongoing pregnancy rate
Up to 12 weeks
Non-Invasive Prenatal Testing (NIPT)
Up to 20 weeks
Analysis of the Products of Conception (POC)
Month 6
Clinical miscarriage rate
Time to get an ongoing pregnancy

Trial Safety

Safety Progress

1 of 3

Other trials for Infertility

Trial Design

2 Treatment Groups

Control group (group 1)
1 of 2
Intervention group (group 2)
1 of 2
Active Control
Experimental Treatment

This trial requires 1108 total participants across 2 different treatment groups

This trial involves 2 different treatments. NiPGT-A is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention group (group 2)
DiagnosticTest
Deferred single blastocyst transfer with blastocyst selection according to the analysis of the spent culture media (niPGT-A).
Control group (group 1)
Other
Deferred single blastocyst transfer with blastocyst selection according to morphology.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months after the ovum pick-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months after the ovum pick-up for reporting.

Closest Location

Fertility Associates of California (FSAC) - Thousand Oaks, CA

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
IVF patients intending to undergo deferred day 6/7 blastocyst SET for any medical indication.
All the oocytes/embryos from the cycle should follow the laboratory protocol described in the study (embryo culture and vitrification on day 6/7).
ICSI, IVF or ICSI/IVF performed in fresh own oocytes from couples not undergoing PGT-A. Note: Donor sperm is allowed.
Female age: 20-40 years, both included.

Patient Q&A Section

What are the signs of aneuploidy?

"The clinical presentation of a baby with Down syndrome can differ from that of an individual with trisomy 18. The most common signs of Down syndrome are mild or no learning disabilities and facial features typically associated with autism. There are no specific symptoms associated with trisomy 18." - Anonymous Online Contributor

Unverified Answer

Can aneuploidy be cured?

"Aneuploidy cannot be cured. However, the impact of aneuploidy on development and disease is variable. Some individuals with aneuploidy may have an increased risk of birth defects, mental retardation, and cancer, but others may have an increased risk of developmental delay, hyperactivity, or seizures. Aneuploidy is a risk factor for schizophrenia. The overall impact of aneuploidy may be minimal, or absent altogether." - Anonymous Online Contributor

Unverified Answer

What causes aneuploidy?

"The main cause of aneuploidy is non-disjunction during cell division. Other factors that can contribute to aneuploidy include chromosomal abnormalities caused by gene damage during mitosis (as in cases involving genetic syndromes that predispose to cancer) and chromosome loss after DNA replication (as in cases involving chromosomal abnormalities without a specific predisposition to cancer)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for aneuploidy?

"While there is usually no obvious treatment for aneuploidy, when indicated, treatment is not necessarily harmful. It may be recommended to treat aneuploidy on a case-by-case basis. At present any form of therapy can be harmful to the fetus, and therefore is not recommended. For pregnancies that are known to have aneuploidy, treatment is recommended. For the rest of the patients, further monitoring of the child after childbirth is necessary." - Anonymous Online Contributor

Unverified Answer

What is aneuploidy?

"Aneuploidy is a common cause of miscarriage in the first trimester. More study needs to be carried out to establish the causes and effects of aneuploidy." - Anonymous Online Contributor

Unverified Answer

How many people get aneuploidy a year in the United States?

"Data from a recent study indicate that more than 3,000 fetuses in the United States are born aneuploid each year and therefore should be identified as fetuses at risk of adverse events. Although aneuploidy is an important cause of prenatal and neonatal deaths and disabilities, this is the first study to demonstrate a significant increase in the number of cases of aneuploidy each year in North America; consequently, there is a growing need for better diagnosis and better strategies for surveillance of patients with aneuploidy. In view of the increasing frequency and seriousness of aneuploidy, efforts need to be made to expand the detection and medical management of fetuses at risk." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets aneuploidy?

"While the age range for individuals is large, the average age for individuals is 35 years. This finding is of more than just limited interest to the medical research community; it is imperative that patients, their families, and the general public have a better understanding of the average age that a patient who is known to be a carrier of aneuploidy will undergo prenatal testing." - Anonymous Online Contributor

Unverified Answer

Does aneuploidy run in families?

"For the first time, aneugenetic and aploidy profiling was carried out by fluorescent gel electrophoresis and karyotyping in a large set of a large family (20 members in total). Results from a recent clinical trial suggest a strong genetic and/or environmental basis for aneuploidy. The analysis of a large number of individuals confirms already known a priori family risks of aneuploidy (17.3% in first-degree relationship), but also reveals new aneugenic families at low familial load. In the future, these data will be valuable in understanding the environmental effects on the reproductive process. They may not be applicable to all pedigrees, however." - Anonymous Online Contributor

Unverified Answer

What is nipgt-a?

"The two genes mentioned were found to be associated with aneuploidy in humans. They appeared to be functionally related, as expression of nipgt-a was detected only in clones containing the extra nipgt-a copy and was not detected in clones containing only one of the two alleles of an additional gene. Considering that aneuploidy in humans is usually diagnosed and characterized through fluorescence in situ hybridization, our findings provide further evidence that the nipgt-a gene is indeed and important for aneuploidy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of aneuploidy?

"The following associations can contribute to aneuploidy: maternal, paternal or both in the case of the latter. Also, the presence of both gametes with chromosomal loss seems to be associated with a higher frequency, compared with the presence of a single aneuploid gamete, the aneuploidy occurring in the absence of such gametes." - Anonymous Online Contributor

Unverified Answer

Is nipgt-a safe for people?

"Gene-based preimplantation genetic tests are safe for women, particularly for women not contemplating ART, although the test information is not available immediately. Clinics should consider offering test information at the time of counselling, and women undergoing ART should be informed of the test information." - Anonymous Online Contributor

Unverified Answer

What does nipgt-a usually treat?

"This is the first reported use of a new anti-GATA4-based clinical approach to the treatment of patients with aneuploidy. Although there was one patient with persistent disease remission, further research is warranted." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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