CompletedNot Applicable

Single Embryo TrAnsfeR of Euploid Embryo

United States, Australia, Canada661 participantsStarted 2014-09

Plain-language summary

The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All embryos will be vitrified and a single embryo transfer (SET) will be performed with either screened or unscreened embryos depending on randomization.

Who can participate

Age range

25 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient undergoing IVF * At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development Exclusion Criteria: * History of more than two prior implantation failure following IVF * History of more than one miscarriage of viable pregnancy * One or both partners known to be carrier(s) of a chromosomal abnormality * Known genetic carrier couple and/or one or both partners carrier of a known autosomal dominant disorder * Any other non-study related preimplantation genetic testing * Use of donor oocytes * Use of gestational carrier (surrogate or donor egg recipient). * Severe oligospermia (\<1,000,000 sperm/ml); Surgical Sperm Retrieval for reasons other than post-vasectomy and CAVD * Low ovarian reserve with (FSH) \>10 IU/L on day 2-4 of a prior menstrual cycle and/or (AMH) \<7 pmol/L (or \<1 ng/ml) * Gender selection cycles * Concurrent participation in another clinical trial

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ongoing Pregnancy

Timeframe: Gestational Age of 20 Weeks

Trial details

NCT IDNCT02268786

SponsorIllumina, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-31

Results submitted2020-04-22

View on ClinicalTrials.gov More Infertility trials