CompletedNot Applicable

Sperm Selection by Microfluidic Separation Improves Embryo Quality

United States393 participantsStarted 2017-06-20

Plain-language summary

This is a randomized controlled trial of couples with a history of poor embryo quality undergoing a repeat in vitro fertilization (IVF) cycle for unexplained infertility. Couples will be randomized to sperm selection by the clinical standard of centrifugation and density-gradient processing compared to the microfluidic sperm sorting chip.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

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: * The target population includes couples planning in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI). * Subjects with and without a history of prior IVF cycles will be included. * All eligible couples where both partners are \>=18 years of age will be asked to join the study. Exclusion Criteria: * Male partner with severe oligoasthenospermia (concentration \< 5 x 10\^6 spermatozoa/mL; motility\< 10%) * Female partner with anovulation (PCOS, FHA) * Female partner age \>41 * Female partner AFC\< 7 * Female partner with obstructed fallopian tubes (assessed in all patients prior to IVF) * Use of oocyte donor * Either Partner: * Cancer diagnosis in either partner * Any significant disease or psychiatric disorder that would interfere with consenting process * Treatment History: o History of \>1 prior cycle cancellation due to poor response * Treatment Plan: * Embryo co-culture * Use of adjunctive non-gonadotropin medications to improve embryo quality: growth hormone, sildenafil

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

Day 3 High Quality Embryo Percentage

Timeframe: 3 days following fertilization

Trial details

NCT IDNCT03085433

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-30

Results submitted2023-05-01

View on ClinicalTrials.gov More Sperm DNA Fragmentation trials