Contact information
Type
Scientific
Primary contact
Dr Lodovico Parmegiani
ORCID ID
Contact details
GynePro Medical Centers
Via T. Cremona
8
Bologna
40137
Italy
l.parmegiani@gynepro.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Institutional Medical Ethics Committee of GynePro Medical Center approved in December 2007
Study design
Single centre prospective randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2010
Overall trial end date
01/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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%)
Recruitment start date
01/09/2010
Recruitment end date
01/03/2011
Locations
Countries of recruitment
Italy
Trial participating centre
GynePro Medical Centers
Bologna
40137
Italy
Sponsor information
Organisation
GynePro Medical Centers (Italy)
Sponsor details
Via T. Cremona 8
Bologna
40137
Italy
l.parmegiani@gynepro.it
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
GynePro Medical Centers (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
MidAtlantic Diagnostic (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list