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Genetic Testing

NGS Embryo Selection for Infertility

Phase 2

Waitlist Available

Research Sponsored by Reprogenetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age up to 42 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during a pregnancy term

Awards & highlights

Study Summary

This trial will compare the effectiveness of a new method of embryo selection (NGS) to the standard method (ART) in terms of implantation rates, miscarriage rates, and pregnancy rates.

Who is the study for?

This trial is for individuals up to 42 years old who are medically cleared for fresh or frozen embryo transfer as part of infertility treatment. It excludes those using certain sperm retrieval methods, egg donors, cycles with thawed embryos, abnormal ovarian reserve indicators, carriers of genetic diseases, and gender selection cycles.Check my eligibility

What is being tested?

The study compares standard Assisted Reproductive Technologies (ART) to the use of Next Generation Sequencing (NGS) after blastocyst biopsy. The goal is to see if NGS improves implantation rates and pregnancy outcomes by analyzing whole chromosomes in embryos before transfer.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical ART-related risks such as discomfort from procedures, emotional stress from uncertain outcomes, and possible complications related to biopsies or handling of embryos.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 42 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ when a fetal heartbeat is detected (8 weeks after implantation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~when a fetal heartbeat is detected (8 weeks after implantation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and when a fetal heartbeat is detected (8 weeks after implantation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

improvement in ongoing implantation rates

Secondary outcome measures

Determine specificity and sensitivity rates

Other outcome measures

Correlation of Mitochondrial DNA and implantation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test - PGSExperimental Treatment1 Intervention

All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5,/6. Embryos will be vitrified. Patients will have a single hatching euploid blastocyst (*) replaced on a thawed cycle.

Group II: Control - Standard ART treatmentActive Control1 Intervention

0 / 1Eligibility criteria met

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Who is running the clinical trial?

ReprogeneticsLead Sponsor

6 Previous Clinical Trials

2,427 Total Patients Enrolled

6 Trials studying Infertility

2,427 Patients Enrolled for Infertility

Main Line Fertility CenterOTHER

4 Previous Clinical Trials

292 Total Patients Enrolled

2 Trials studying Infertility

209 Patients Enrolled for Infertility

Santiago Munne, PhDStudy DirectorReprogenetics

7 Previous Clinical Trials

2,381 Total Patients Enrolled

7 Trials studying Infertility

2,381 Patients Enrolled for Infertility

Media Library

Blastocyst Biopsy with Whole Chromosome Analysis (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT01946945 — Phase 2

Infertility Research Study Groups: Control - Standard ART treatment, Test - PGS

Infertility Clinical Trial 2023: Blastocyst Biopsy with Whole Chromosome Analysis Highlights & Side Effects. Trial Name: NCT01946945 — Phase 2

Blastocyst Biopsy with Whole Chromosome Analysis (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01946945 — Phase 2

Frequently Asked Questions

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

Are there still spots available to register for this research endeavor?

"This medical trial, which was initially listed on September 1st 2013 and last updated in 2014, is not currently recruiting. However, there are 254 other studies actively seeking participants at this present moment."

Answered by AI

To what extent may Next Generation Sequencing following Blastocyst biopsy be detrimental to individuals?

"Our Power team has assigned Next Generation Sequencing after Blastocyst biopsy a score of 2 out of 3, as the Phase 2 trial data provides evidence for safety but not efficacy."

Answered by AI

Who is eligible to participate in this clinical investigation?

"For this infertility research study, 240 participants aged 18 to 42 are being recruited. In addition, all subjects must meet the maximum age qualification of 42 years old."

Answered by AI