PICSI RCT in Couples With a Previous Poor Fertilisation Cycle in IVF

Status Recruiting

Clinical Trial Summary

Poor fertilisation plays a significant role in poor artificial reproductive technique outcomes. Male factor infertility accounts for a large portion of such cases. Several modalities have been proposed as a solution, including physiological intra-cytoplasmic sperm injection (PICSI). PICSI is a technique used to select the sperm to use in intra-cytoplasmic sperm injection (ICSI) treatment. It involves placing sperm with hyaluronic acid, a natural compound found in the body. PICSI identifies sperm that can bind to hyaluronic acid and these sperms are selected for use in treatment. Some studies have suggested that PISCI may be advantageous to reduce miscarriage. However, the evidence is not strong and it remains unknown if PICSI is effective in a selected group of couples with a history of poor fertilisation. Based on previous medical records, we observed a higher clinical pregnancy rate (CPR) and a trend towards lower miscarriage rates with PICSI. To verify the findings and address the clinical gap, we propose a randomised controlled trial (RCT) with 234 couples (117 in each group) to evaluate the effectiveness of PICSI comparing with ICSI for improving CPR and reducing miscarriage rate in couples with a fertilisation rate of <50% in their first cycle of ICSI.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05017740
Study type	Interventional
Source	KK Women's and Children's Hospital
Contact	Xiang Wen Ng, MPH
Phone	+65 63948113
Email	ng.xiang.wen@kkh.com.sg
Status	Recruiting
Phase	N/A
Start date	March 15, 2022
Completion date	August 2024

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