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
Secondary identifying numbers	N/A

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

GynePro Medical Centers
Via T. Cremona, 8
Bologna
40137
Italy

Email	l.parmegiani@gynepro.it

Study information

Study design	Single centre prospective randomised study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient 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	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
Secondary outcome measures	Duration of ICSI procedure, measured at time of oocyte insemination
Overall study start date	01/09/2010
Completion date	01/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Sponsor information

GynePro Medical Centers (Italy)
Industry

Via T. Cremona 8
Bologna
40137
Italy

Email	l.parmegiani@gynepro.it
Website	http://www.gynepro.it
"ROR"	https://ror.org/03segdh23

Funders

Funder type

Industry

GynePro Medical Centers (Italy)

No information available

MidAtlantic Diagnostic (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

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.