NCT01916213

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: St. Luke's-Roosevelt Hospital Center · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

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

Conditions

• Infertility

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-08-05
• Last updated: 2015-10-14

Locations

1 site across 1 country: United States