Male Factor InfertilityNCT00741494
Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)
A study testing PICSI dish in people with Male Factor Infertility, run by Biocoat at 9 sites in United States.
Trial summary
The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select sperm for ICSI will result in increased pregnancies especially with men that have a low hyaluronan binding score (HBA). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Male Factor Infertility
- What is being tested?
- PICSI dish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- IVF patients who require the ICSI procedure and whose care is being managed by the clinical and scientific staff of the participating groups, will be included in the study.
Who cannot join
- IVF patients who do not require the ICSI procedure will be excluded from the study. In addition the following groups of patients will also be excluded:
- Patients using testicular sperm.
- Patients using donor sperm.
- Patients where the female partner is over 40 years of age
- Patients who have an initial HBA score less than or equal to 2%
- Patients who have a sperm count less than or equal to 10,000 motile sperm per ml.
- Patients who produce less than 4 Metaphase II oocytes
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Abington IVF and Genetics Toll Center for Reprodcution
Abington, Pennsylvania, 19001
Georgia Reproductive Specialists
Atlanta, Georgia, 30342
Reproductive Biology Associates
Atlanta, Georgia, 30342
Fertility Centers of Illinois
Chicago, Illinois, 60610
Huntington Reproductive Center
Laguna Hills, California, 92653
Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02903
Reproductive Science Center of the Bay Area
San Ramon, California, 94583
Seattle Reproductive Medicine
Seattle, Washington, 98109
CNY Fertility Center
Syracuse, New York, 13205
About this study
Official title: Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI) for Patients Having a Low Versus High Proportion of Hyaluronan Binding Sperm (HBA)
The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select sperm for ICSI will result in increased pregnancies especially with men that have a low hyaluronan binding score (HBA).
- Conditions
- Male Factor Infertility
- Being tested
- PICSI dish
- Keywords
- infertility, ICSI, hyaluronan binding, sperm, sperm selection, male factor, hyaluronan, sperm maturity, clinical pregnancy rates, hyaluronan binding assay, HBA, PICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICSI dishDevice
Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | HBA score over 65% control |
| 2 | No intervention | HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores) |
| 3 | Active comparator | HBA score over 65%. PICSI dish is used to select the sperm for ICSI. Receives: Device: PICSI dish |
| 4 | Experimental | HBA score less than 65%. PICSI dish used to select sperm for ICSI. Receives: Device: PICSI dish |
| 5 | No intervention | HBA Score less than 65%. Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 8 weeks post ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male Factor InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocoat
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kathryn Worrilow, Ph.D., Study director, Biocoat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741494
- Sponsor's protocol ID
- 2008PICSI03
- Status last verified
- Dec 2010
- First submitted
- 25 Aug 2008
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Worrilow KC, Eid S, Woodhouse D, Perloe M, Smith S, Witmyer J, Ivani K, Khoury C, Ball GD, Elliot T, Lieberman J. Use of hyaluronan in the selection of sperm for intracytoplasmic sperm injection (ICSI): significant improvement in clinical outcomes--multicenter, double-blinded and randomized controlled trial. Hum Reprod. 2013 Feb;28(2):306-14. doi: 10.1093/humrep/des417. Epub 2012 Nov 30.
PubMed 23203216
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI) for Patients Having a Low Versus High Proportion of Hyaluronan Binding Sperm (HBA)
- ClinicalTrials.gov ID
- NCT00741494
- Acronym / sponsor ID
- 2008PICSI03
- Conditions
- Male Factor Infertility
- Keywords
- infertility, ICSI, hyaluronan binding, sperm, sperm selection, male factor, hyaluronan, sperm maturity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- BiocoatIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2010 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select sperm for ICSI will result in increased pregnancies especially with men that have a low hyaluronan binding score (HBA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –HBA score over 65% control |
| 2 | No intervention | –HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores) |
| 3 | Active comparator | Device: PICSI dishHBA score over 65%. PICSI dish is used to select the sperm for ICSI. |
| 4 | Experimental | Device: PICSI dishHBA score less than 65%. PICSI dish used to select sperm for ICSI. |
| 5 | No intervention | –HBA Score less than 65%. Control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- IVF patients who require the ICSI procedure and whose care is being managed by the clinical and scientific staff of the participating groups, will be included in the study.
Key exclusion criteria (7 listed)
- IVF patients who do not require the ICSI procedure will be excluded from the study. In addition the following groups of patients will also be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICSI dishSperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI | Device | 3, 4 |
Primary outcome
Clinical pregnancy rate
Time frame: 8 weeks post ICSI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
- Derived from this study: PubMed 23203216Worrilow KC, Eid S, Woodhouse D, Perloe M, Smith S, Witmyer J, Ivani K, Khoury C, Ball GD, Elliot T, Lieberman J. Use of hyaluronan in the selection of sperm for intracytoplasmic sperm injection (ICSI): significant improvement in clinical outcomes--multicenter, double-blinded and randomized controlled trial. Hum Reprod. 2013 Feb;28(2):306-14. doi: 10.1093/humrep/des417. Epub 2012 Nov 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Worrilow, Ph.D. study director
Biocoat
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICSI dish in people with Male Factor Infertility, run by Biocoat at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 8 weeks post ICSI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00741494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2010.