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Genetic Testing

niPGT-A for Infertility (niPGT-A_RCT Trial)

N/A
Recruiting
Led By Carmen Rubio, PhD
Research Sponsored by Igenomix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All the oocytes/embryos from the cycle should follow the laboratory protocol described in the study (embryo culture and vitrification on day 6/7).
Female age: 20-40 years, both included.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after the ovum pick-up
Awards & highlights

niPGT-A_RCT Trial Summary

This trial will analyze whether prioritizing embryos for transfer based on their cfDNA content in the SBM can improve pregnancy rates.

Who is the study for?
This trial is for IVF patients aged 20-40 who are planning to have a single embryo transfer on day 6/7 without prior genetic testing. They must follow the study's lab protocol and provide informed consent. Excluded are those with significant uterine issues, unstable medical conditions, or specific treatments like assisted hatching before sample collection.Check my eligibility
What is being tested?
The trial tests non-invasive Preimplantation Genetic Testing for Aneuploidy (niPGT-A) by analyzing cell-free DNA in Spent Blastocyst Medium against standard morphology criteria. It aims to improve pregnancy rates by selecting embryos with higher implantation potential.See study design
What are the potential side effects?
Since niPGT-A involves analysis of culture media rather than the embryo itself, it reduces risks associated with invasive biopsy procedures used in traditional PGT-A methods.

niPGT-A_RCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My eggs or embryos will be handled according to the study's lab protocol.
Select...
I am a woman aged between 20 and 40.

niPGT-A_RCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after the ovum pick-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after the ovum pick-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-invasive analysis of the chromosomal status of the embryo
Ongoing pregnancy rate
Secondary outcome measures
Analysis of the Products of Conception (POC)
Clinical miscarriage rate
Cumulative live birth rate
+6 more

niPGT-A_RCT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention group (group 2)Experimental Treatment1 Intervention
Deferred single day 6/7 blastocyst transfer with blastocyst selection according to the analysis of the spent culture media (niPGT-A).
Group II: Control group (group 1)Active Control1 Intervention
Deferred single day 6/7 blastocyst transfer with blastocyst selection according to morphology.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
niPGT-A
2018
N/A
~2590

Find a Location

Who is running the clinical trial?

IgenomixLead Sponsor
35 Previous Clinical Trials
15,323 Total Patients Enrolled
12 Trials studying Infertility
9,157 Patients Enrolled for Infertility
Carlos Simón, MD PhDStudy ChairIgenomix S.L.
6 Previous Clinical Trials
3,651 Total Patients Enrolled
3 Trials studying Infertility
3,406 Patients Enrolled for Infertility
Carmen Rubio, PhDPrincipal InvestigatorIgenomix S.L.
4 Previous Clinical Trials
540 Total Patients Enrolled
2 Trials studying Infertility
290 Patients Enrolled for Infertility

Media Library

niPGT-A (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT04000152 — N/A
Infertility Research Study Groups: Control group (group 1), Intervention group (group 2)
Infertility Clinical Trial 2023: niPGT-A Highlights & Side Effects. Trial Name: NCT04000152 — N/A
niPGT-A (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04000152 — N/A
Infertility Patient Testimony for trial: Trial Name: NCT04000152 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals does this research hope to achieve?

"The purpose of this 12-week clinical study is to analyze an embryo's chromosomes without invasively collecting tissue samples. Additionally, we will be looking at the results of next generation sequencing (NGS) applied to the SBM, informativity rates and prioritization category of the SBM analysis results in relation to embryo development, culture conditions and collection time, as well as the cumulative live birth rate and ongoing pregnancy rate in the 6 months following treatment."

Answered by AI

What are the prerequisites for enrolling in this clinical trial?

"This study is looking for 1108 participants that have struggled with infertility between the ages of 20 and 40. The most important criteria that applicants should meet are as follows: Patients who have given written informed consent approved by the Ethics Committee (EC), after being made aware of what the study entails and voluntarily deciding to participate., 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"

Answered by AI

How many individuals have signed up to participate in this research trial?

"That is correct, the online information indicates that the trial is still recruiting individuals. The first posting was on June 14th, 2019 with the most recent update being December 30th, 2020. There is a goal to enroll 1,108 patients from a single location."

Answered by AI

Does this research include middle-aged or older adults in the subject pool?

"This particular clinical trial only accepts patients aged 20 through 40 that meet the other listed requirements. In contrast, there are 21 trials for those under 18 and 39 for senior citizens."

Answered by AI

Are there any patients who have not yet been enrolled in this research project?

"The clinical trial currently posted on clinicaltrials.gov is actively recruiting participants. The study was originally posted on 6/14/2019 and was last updated on 12/30/2020."

Answered by AI

Who else is applying?

What state do they live in?
Utah
Tennessee
California
Other
How old are they?
18 - 65
What site did they apply to?
Boston IVF Fertility Clinic
Centro Procreazione Assistita DEMETRA
Fertility Associates of California (FSAC)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0

Why did patients apply to this trial?

I hope this clinical child will help me achieve becoming pregant. I’ve had infertility for several years and am hoping this can help me.
PatientReceived 2+ prior treatments
My husband and I had a ectopic pregnancy and we don’t know why. I was told that this is the first tome they have ever saw and ectopic abort itself without meds, surgery or patient dying.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long would the whole process take?
PatientReceived no prior treatments
~181 spots leftby Feb 2025