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

Last updated: August 26, 2025
Sponsor: KK Women's and Children's Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Infertility

In Vitro Fertilization

Treatment

ICSI

PICSI

Clinical Study ID

NCT05017740
2021/RM/001
  • Ages 21-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Couples with <50% fertilisation in their first ICSI cycle, and scheduled for theirsecond ICSI/PICSI cycle

Exclusion

Exclusion Criteria:

  • Women with diminished ovarian reserves (AMH <1.2ng/ml) or severe endometriosis (rAFSStage III or IV)

  • Male partner with severe oligoasthenoteratozoospermia (Density < 5 million, Totalmotility < 40) or those require surgically retrieved sperm

  • Couples using donor gametes

  • Couples using frozen gametes

  • Couples undergoing split IVF-ICSI cycles

  • Couples where a freeze all approach has been done, either clinically indicated orsecondary to patient choice

Study Design

Total Participants: 47
Treatment Group(s): 2
Primary Treatment: ICSI
Phase:
Study Start date:
March 15, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • KK Women's and Children's Hospital

    Singapore, 229899
    Singapore

    Site Not Available

  • KK Women's and Children's Hospital

    Singapore 1880252, 229899
    Singapore

    Site Not Available

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