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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: PICSI

• Registration Number: NCT01916213
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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:

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ICSI	PICSI	-
PICSI	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

Primary Outcome Measures

Name	Time	Method
implantation rate	12 months

Secondary Outcome Measures

Name	Time	Method
fertilization rate	12 months

Trial Locations

Locations (1)

Continuum Reproductive Center; 🇺🇸 New york, New York, United States