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The Valve of Hyaluronic Binding Selection (PICSI) in Improving IVF Outcome

Sponsor
St. Luke's-Roosevelt Hospital Center (Other)
Overall Status
Completed
CT.gov ID
NCT01916213
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
15
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators would like to assess whether selecting mature sperm using PICSI (selecting for sperm that bind hyaluronan) can optimize the IVF outcome of ICSI .

Aim

  1. Primary outcome: To compare routine sperm selection using ICSI with sperm selection using PICSI plates in terms of implantation and fertilization rates for couples with male factor fertility

  2. Secondary outcome : To compare live birth rates ,ongoing pregnancies and miscarriage rates for couples with male factor infertility using routine sperm selection with ICSI compared to using PICSI plates for sperm selection

Hypothesis:

Sperm selected for ICSI using (PICSI) will reveal increased implantation rates in comparison to sperm selected for conventional ICSI

Condition or Disease Intervention/Treatment Phase
  • Procedure: PICSI
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PICSI

PICSI dish ( MidAtlantic Diagnostics Inc) has been developed to select the specific sperm to be used for the ICSI procedure using the same principles as the Sperm Hyaluronan Binding Assay. HA-mediated ICSI sperm selection( PICSI) uses Falcon Petri dishes that feature three microdots of hyaluronan hydrogel attached to the interior bottom: mature, biochemically competent spermatozoa bind to hyaluronan, where they can be isolated and used for ICSI

Procedure: PICSI
If the oocytes are randomized to ICSI during the retrieval they will be ordered by the 1,4,5 8th best oocyte and PICSI to the 2,3, 6 7th best oocytes or the reverse if PICSI is selected. If one cohort is superior that cohort should be chosen by the blinded physician and the alternate cohort frozen or discarded based on their quality. This will ensure that the couple will always have the opportunity to have good quality embryo transferred regardless of how they are randomized. If there are no good quality embryos in the selected cycle we will consider it a failed transfer for that cycle and we will transfer the good quality embryos from the non- selected group as a fresh embryo transfer. For example if a couple is randomized to ICSI and all the ICSI embryos are poor quality but the PICSI embryos are good quality we will consider it a failed ICSI transfer and transfer the PICSI embryos as a fresh embryo transfer.
Other Names:
  • The PICSI® dish is based on the research documenting that mature and structurally sound sperm will bind to hyaluronan.
  • CE marked (CE 0120)

    		•
    Active Comparator: ICSI

    Procedure: PICSI
    If the oocytes are randomized to ICSI during the retrieval they will be ordered by the 1,4,5 8th best oocyte and PICSI to the 2,3, 6 7th best oocytes or the reverse if PICSI is selected. If one cohort is superior that cohort should be chosen by the blinded physician and the alternate cohort frozen or discarded based on their quality. This will ensure that the couple will always have the opportunity to have good quality embryo transferred regardless of how they are randomized. If there are no good quality embryos in the selected cycle we will consider it a failed transfer for that cycle and we will transfer the good quality embryos from the non- selected group as a fresh embryo transfer. For example if a couple is randomized to ICSI and all the ICSI embryos are poor quality but the PICSI embryos are good quality we will consider it a failed ICSI transfer and transfer the PICSI embryos as a fresh embryo transfer.
    Other Names:
  • The PICSI® dish is based on the research documenting that mature and structurally sound sperm will bind to hyaluronan.
  • CE marked (CE 0120)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. implantation rate [12 months]

    Secondary Outcome Measures

    1. fertilization rate [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • In order to participate in the study women must be 42 years old or younger and suffer from male factor infertility however they may have other causes for their infertility

    • male factor infertility as defined by one or more of the following sperm parameters: <20 Million /ml sperm concentration < 30% normal morphology < 3% Kruger morphology < 50% motility sion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Continuum Reproductive Center New york New York United States 10019

    Sponsors and Collaborators

    • St. Luke's-Roosevelt Hospital Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St. Luke's-Roosevelt Hospital Center
    ClinicalTrials.gov Identifier:
    NCT01916213
    Other Study ID Numbers:
    • IRB # 12-065
    First Posted:
    Aug 5, 2013
    Last Update Posted:
    Oct 14, 2015
    Last Verified:
    Aug 1, 2014
    Additional relevant MeSH terms:
    Infertility
    Hyaluronic Acid

    Study Results

    No Results Posted as of Oct 14, 2015