Comparison of two ready-to-use systems specially designed for physiological intracytoplasmic sperm injection (ICSI): PICSI® versus Sperm Slow™, a prospective randomised trial
| ISRCTN | ISRCTN72668039 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72668039 |
| Protocol serial number | N/A |
| Sponsor | GynePro Medical Centers (Italy) |
| Funders | GynePro Medical Centers (Italy), MidAtlantic Diagnostic (USA) |
- Submission date
- 24/08/2010
- Registration date
- 11/10/2010
- Last edited
- 18/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lodovico Parmegiani
Scientific
Scientific
GynePro Medical Centers
Via T. Cremona, 8
Bologna
40137
Italy
| l.parmegiani@gynepro.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre prospective randomised study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of two ready-to-use systems specially designed for sperm-hyaluronic acid (HA) binding selection before intracytoplasmic sperm injection (physiological ICSI): PICSI® versus Sperm Slow™, a prospective randomised trial |
| Study objectives | The objective of this study is to evaluate the role of hyaluronic acid (HA) for sperm selection prior to intracytoplasmic sperm injection (ICSI) comparing two ready-to-use systems specially designed for sperm-HA binding selection: a plastic culture dish with microdots of HA hydrogel attached to the bottom interior of the dish (PICSI® Sperm Selection Device, MidAtlantic Diagnostic) or a viscous medium containing HA (Sperm Slow™, MediCult). These systems, in which the spermatozoa are selected for their capacity to bind to HA (HA-ICSI), allow the execution of a more "physiological" ICSI than conventional PVP-ICSI. |
| Ethics approval(s) | Institutional Medical Ethics Committee of GynePro Medical Center approved in December 2007 |
| Health condition(s) or problem(s) studied | Intracytoplasmic sperm injection (ICSI) |
| Intervention | 100 ICSI treatments randomly carried out with PICSI® Sperm Selection Device or with Sperm Slow™ for sperm selection. Randomisation process conducted with sealed envelopes, assigning 50 subjects to each treatment group. Controlled ovarian stimulation with gonadotropin-releasing hormone analogs in combination with a graded gonadotropin administration. Oocyte retrieval performed 35 hours after ovulation induction with either 5,000 or 10,000 IU of human chorionic gonadotropin (hCG). Oocytes culture at 37°C in an atmosphere of 6% CO2. Complete removal of cumulus mass and corona cells by enzymatic digestion of recombinant hyaluronidase (SynVitro® Cumulase® MediCult) and by gentle mechanical aspiration with plastic pipettes (Stripper Tips® MidAtlantic Diagnostic). Assessment of the nuclear maturation stage of the denuded oocytes. Strict selection of the metaphase II oocytes (MII) by morphological features (zona pellucida thickness, perivitelline space size, oocyte shape, cytoplasm colour and granularity, presence of vacuoles and first polar body morphology) under an inverted microscope with Hoffman modulation contrast. Classification of "high quality oocytes": colourless and of regular shape, with regular zona pellucida and small perivitelline space without debris, homogeneous cytoplasm and no vacuoles or granulations. Insemination by ICSI of the best available MII oocytes, in accordance with the Italian law regulating Assisted Reproductive Technology (cryopreservation of the supernumerary MII oocytes reaching the "high quality" standards). PICSI® Sperm Selection Device procedure as described in www.midatlanticdiagnostics.com. Sperm Slow™ ICSI procedure: Spermatozoa must first be treated with a two-layer density gradient system or via Swim-Up. Thus, on a Petri dish, a 2 µL droplet with suspension of treated spermatozoa is connected with a pipette tip to a 5 µL droplet fresh culture medium (Sperm Preparation Medium, MediCult). Simultaneously, A 5 µL droplet of HA-containing medium (Sperm Slow™, MediCult) is connected with a pipette tip to the 5 µL droplet fresh culture medium. The spermatozoa on this Petri dish are incubated for 15 min at 37°C under oil (Liquid Paraffin, MediCult). Spermatozoa bound to HA in the junction zone of the 2 droplets can be selected and easily detached by injecting pipette (ICSI Micropipets, Humagen Fertility Diagnostics) and subsequently injected into oocytes. Controlled ovarian stimulation duration: from 12 to 20 days Oocyte recovery, ICSI, embryo culture and embryo transfer duration: from 3 to 5 days The follow up will be completed at confirmation of clinical pregnancy by ultrasound check of gestational chamber, 30 days after the embryo transfer. |
| Intervention type | Other |
| Primary outcome measure(s) | 1. Oocyte fertilisation rate, measured 15 - 22 hours after oocyte insemination 2. Embryo cleavage rate, measured at day of embryo transfer (2, 3 or 5 days after oocyte insemination) 3. Top-quality embryo rate, measured at day of embryo transfer (2, 3 or 5 days after oocyte insemination) 4. Pregnancy rate, measured 30 days after the embryo transfer 5. Implantation rate, measured 30 days after the embryo transfer |
| Key secondary outcome measure(s) | Duration of ICSI procedure, measured at time of oocyte insemination |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Infertile women not older than 41 years undergoing ICSI treatment at GynePro Medical Center 2. Semen parameters of the male partner: 2.1. Presence of ejaculate motile spermatozoa with total sperm number greater than or equal to 1,000,000 2.2. Sperm motility greater than or equal to 5% |
| Key exclusion criteria | 1. Women older than 41 years old 2. Patients with male partners with testicular spermatozoa or severe oligoastenoteratozoospermia (total sperm number less than 1,000,000 and sperm motility less than 5%) |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
GynePro Medical Centers
Bologna
40137
Italy
40137
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2012 | 18/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
