NCT05017740

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

A Randomised Clinical Trial in the Use of Physiological Intra-cytoplasmic Spermatozoa Injection (PICSI) in Couples With a Previous Poor Fertilisation Cycle in In-vitro Fertilisation.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility
• IVF

Interventions

Type	Name	Description
PROCEDURE	ICSI	In ICSI, the sperm is chosen based on motility and gross morphology to be inseminated directly into the cytoplasm of the oocyte.
PROCEDURE	PICSI	In PICSI, the sperm is selected via hyaluronic binding before insemination into the cytoplasm of the oocyte.

Timeline

• Start date: 2022-03-15
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-08-24
• Last updated: 2025-08-27

Locations

1 site across 1 country: Singapore