Condition category
Pregnancy and Childbirth
Date applied
24/08/2010
Date assigned
11/10/2010
Last edited
11/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.gynepro.it

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes