InfertilityNCT06602687
PICSI Impact on Euploidy in Assisted Reproduction
A study testing PICSI in people with Infertility, run by Merrion Fertility Clinic at 1 site in Ireland.
Trial summary
Hyaluronic acid (HA) is a major component of the cumulus complex surrounding oocytes. Intracytoplasmic sperm injection (ICSI) involves injection of a selected sperm into the oocyte. Embryologists select sperm with normal morphology and progressive motility. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Infertility
- What is being tested?
- PICSI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2024to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Couples undergoing a planned ICSI-PGT-A cycle using their own fresh gametes
- Female age > 35 years and/or Male age > 40 years
- Minimum of two mature eggs at time of egg maturity assessment
Who cannot join
- Couples undergoing a planned IVF cycle (even if converted to ICSI)
- Patients using donor gametes for an ICSI cycle
- Patients using frozen gametes for an ICSI cycle
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Merrion Fertility Clinic
Dublin, Dublin, D02 NH93
Louise E Glover, PhD, 353 + 15567900, lglover@merrionfertility.ie
David Crosby, MD
About this study
Official title: Sperm Hyaluronic Binding Selection (PICSI): Impact on Embryo Aneuploid Status in Assisted Human Reproduction
Hyaluronic acid (HA) is a major component of the cumulus complex surrounding oocytes. Intracytoplasmic sperm injection (ICSI) involves injection of a selected sperm into the oocyte. Embryologists select sperm with normal morphology and progressive motility. Physiologic intracytoplasmic sperm injection (PICSI) involves sperm selection for ICSI based on hyaluronan binding. Mature sperm which bind to HA have greater genomic integrity and reduced levels of DNA fragmentation. Earlier observational studies demonstrated improved outcomes in assisted reproductive technologies (ART) including improved clinical pregnancy rates, decreased miscarriage rates and higher live birth rates. A large multicentre randomized trial, the HABSelect trial, which included over 2,500 couples, found that PICSI did not improve term (>37 weeks gestation) live birth rates compared to standard ICSI. However, mechanistic analysis of the data from the HABSelect trial showed a significant reduction in miscarriage rates, most notable in couples where the woman was aged over 37 years where a significant reduction in miscarriage rate was seen (40% with ICSI vs 15% with PICSI). A 2021 retrospective sibling oocyte study, including 45 cycles, compared fertilisation and embryo development and found higher fertilisation rate in PICSI cycles. No difference was observed in clinical pregnancy rates; miscarriage rates and live birth rates were not reported. We aim to prospectively study PICSI vs standard ICSI in sibling oocytes to investigate if PICSI improves embryological and ART outcomes, particularly fertilisation rate, embryo euploid status and miscarriage rate, where the female patient is aged over 35 years.
- Conditions
- Infertility
- Being tested
- PICSI
- Keywords
- PICSI, Sperm, Aneuploidy
- Medical subject headings
- Infertility, Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICSIDevice
The PICSI® dish is a CE marked medical device containing dots of a HA hydrogel (Cooper Surgical).
| Study group | Role | What they receive |
|---|---|---|
| Standard ICSI | No intervention | ICSI performed using standard sperm selection methods. |
| PICSI | Experimental | ICSI performed using sperm selected based on hyaluronan binding (PICSI® dish, Cooper Surgical). Receives: Device: PICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euploidy rates
Primary outcome is rate of euploid embryos per cycle after preimplantation genetic testing for aneuploidy (PGT-A)
Measured: 4 weeks
Secondary outcomes (6)
Fertilisation rates
Defined as number of 2PNs per oocyte injected
Measured: 24-48 hours
Blastocyst development and rate
Assessed on day 5 and day 6 according to Gardner grading system.
Measured: 5 and 6 days
Positive hCG rate
Defined as detection of urinary human chorionic gonadotropin (hCG) per embryo transfer cycles.
Measured: 6-7 weeks
Clinical pregnancy rate
Defined as number of fetal heartbeats/ gestational sacs identified by ultrasonographic visualisation at 6-7 weeks gestation per cycles started, oocyte retrievals or embryo transfer cycles.
Measured: 6-7 weeks
Miscarriage rate
Defined as number of spontaneous losses of an intra-uterine pregnancy prior to 22 completed weeks of gestational age per embryo transfer cycles.
Measured: up to 22 weeks
Live birth rate
Defined as number of live births at ≥37 weeks gestation per embryo transfer cycles
Measured: 37-42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merrion Fertility Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Crosby, MD, Study director, Merrion Fertility Clinic and the National Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602687
- Sponsor's protocol ID
- MFC3
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm Hyaluronic Binding Selection (PICSI): Impact on Embryo Aneuploid Status in Assisted Human Reproduction
- ClinicalTrials.gov ID
- NCT06602687
- Acronym / sponsor ID
- MFC3
- Conditions
- Infertility
- Keywords
- PICSI, Sperm, Aneuploidy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Merrion Fertility ClinicUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
Hyaluronic acid (HA) is a major component of the cumulus complex surrounding oocytes. Intracytoplasmic sperm injection (ICSI) involves injection of a selected sperm into the oocyte. Embryologists select sperm with normal morphology and progressive motility. Physiologic intracytoplasmic sperm injection (PICSI) involves sperm selection for ICSI based on hyaluronan binding. Mature sperm which bind to HA have greater genomic integrity and reduced levels of DNA fragmentation. Earlier observational studies demonstrated improved outcomes in assisted reproductive technologies (ART) including improved clinical pregnancy rates, decreased miscarriage rates and higher live birth rates. A large multicentre randomized trial, the HABSelect trial, which included over 2,500 couples, found that PICSI did not improve term (>37 weeks gestation) live birth rates compared to standard ICSI. However, mechanistic analysis of the data from the HABSelect trial showed a significant reduction in miscarriage rates, most notable in couples where the woman was aged over 37 years where a significant reduction in miscarriage rate was seen (40% with ICSI vs 15% with PICSI). A 2021 retrospective sibling oocyte study, including 45 cycles, compared fertilisation and embryo development and found higher fertilisation rate in PICSI cycles. No difference was observed in clinical pregnancy rates; miscarriage rates and live birth rates were not reported. We aim to prospectively study PICSI vs standard ICSI in sibling oocytes to investigate if PICSI improves embryological and ART outcomes, particularly fertilisation rate, embryo euploid status and miscarriage rate, where the female patient is aged over 35 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ICSI | No intervention | –ICSI performed using standard sperm selection methods. |
| PICSI | Experimental | Device: PICSIICSI performed using sperm selected based on hyaluronan binding (PICSI® dish, Cooper Surgical). |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Couples undergoing a planned ICSI-PGT-A cycle using their own fresh gametes
- Female age > 35 years and/or Male age > 40 years
- Minimum of two mature eggs at time of egg maturity assessment
Key exclusion criteria (3 listed)
- Couples undergoing a planned IVF cycle (even if converted to ICSI)
- Patients using donor gametes for an ICSI cycle
- Patients using frozen gametes for an ICSI cycle
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 |
|---|---|---|
| PICSIThe PICSI® dish is a CE marked medical device containing dots of a HA hydrogel (Cooper Surgical). | Device | PICSI |
Primary outcome
Euploidy rates
Time frame: 4 weeks
Primary outcome is rate of euploid embryos per cycle after preimplantation genetic testing for aneuploidy (PGT-A)
6 secondary outcomes
Fertilisation rates
Time frame: 24-48 hours
Blastocyst development and rate
Time frame: 5 and 6 days
Positive hCG rate
Time frame: 6-7 weeks
Clinical pregnancy rate
Time frame: 6-7 weeks
Miscarriage rate
Time frame: up to 22 weeks
Live birth rate
Time frame: 37-42 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
David Crosby, MD study director
Merrion Fertility Clinic and the National Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICSI in people with Infertility, run by Merrion Fertility Clinic at 1 site in Ireland.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise E Glover, PhD (353 + 15567900, lglover@merrionfertility.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Euploidy rates (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.