What side effects are associated with this type of intervention?

Common treatments for infertility, such as In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI), can have several side effects. These may include ovarian hyperstimulation syndrome (OHSS), which can cause swollen and painful ovaries, multiple pregnancies, which carry higher risks for both mother and babies, and complications from egg retrieval procedures, such as bleeding or infection. Hormonal medications used in these treatments can also lead to mood swings, headaches, and abdominal pain. Additionally, there is a risk of miscarriage and ectopic pregnancy. Non-invasive techniques like cfDNA analysis in spent blastocyst medium aim to reduce some of these risks by avoiding invasive procedures.

What prior FDA approvals exist?

The FDA has approved several treatments for infertility, including medications like clomiphene citrate and assisted reproductive technologies such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). Preimplantation Genetic Testing for Aneuploidy (PGT-A) is a related technique that involves trophectoderm biopsy and Next-Generation Sequencing (NGS) to assess embryo chromosomal status. While non-invasive cfDNA analysis in Spent Blastocyst Medium is a newer approach under investigation, it aims to offer a less invasive and potentially more cost-effective method for evaluating embryo viability compared to traditional invasive techniques.

What other types of research exist?

Promising novel alternatives to non-invasive cfDNA analysis in spent blastocyst medium for detecting embryonic chromosomal status include: 1) Trophectoderm biopsy combined with Next-Generation Sequencing (NGS), which, although invasive, is currently the most accurate method for determining embryo ploidy. 2) Analysis of embryo culture media for genetic material, which is still under research but aims to provide a non-invasive alternative. 3) Advanced imaging techniques and artificial intelligence (AI) algorithms to assess embryo viability and genetic status based on morphological and developmental parameters. These methods are being refined to improve accuracy and reduce invasiveness.

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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.

Must not have

ERA test and embryo transfer according to ERA result.

Couples planning to undergo PGT-M or PGT-SR cases will be excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after the ovum pick-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new, non-invasive method to check embryos for chromosomal issues by analyzing DNA in the culture medium. It aims to help IVF patients who prefer not to use invasive testing. The goal is to improve pregnancy rates by selecting the healthiest embryos without needing invasive procedures. This method emerged from the discovery of embryonic DNA in spent embryo culture medium.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have undergone an ERA test and will follow its recommendations for embryo transfer.

Select...

I am not planning to undergo genetic testing for embryo selection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after the ovum pick-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Non-invasive analysis of the chromosomal status of the embryo

Ongoing pregnancy rate

Secondary study objectives

Analysis of the Products of Conception (POC)

Clinical miscarriage rate

Cumulative live birth rate

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for infertility, such as in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A), work by enhancing the chances of successful conception and healthy pregnancy. IVF involves stimulating the ovaries to produce multiple eggs, retrieving these eggs, fertilizing them with sperm in a lab, and then transferring the resulting embryos into the uterus. PGT-A is used to screen embryos for chromosomal abnormalities before transfer, increasing the likelihood of implantation and reducing the risk of miscarriage. Non-invasive cfDNA analysis in Spent Blastocyst Medium is an emerging technique that aims to assess the genetic health of embryos without the need for invasive biopsies, potentially improving pregnancy outcomes while minimizing risks to the embryo. These treatments are crucial for infertility patients as they offer higher success rates and safer options for achieving a healthy pregnancy.

Impact of inactivated SARS-CoV-2 vaccination on embryo ploidy: a retrospective cohort study of 133 PGT-A cycles in China.Reduced oxygen concentration during human IVF culture improves embryo utilization and cumulative pregnancy rates per cycle.Metabolomics for improving pregnancy outcomes in women undergoing assisted reproductive technologies.