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

NCT ID: NCT05017740

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ICSI

Group Type: ACTIVE_COMPARATOR

ICSI

Intervention Type: PROCEDURE

In ICSI, the sperm is chosen based on motility and gross morphology to be inseminated directly into the cytoplasm of the oocyte.

PICSI

Group Type: ACTIVE_COMPARATOR

PICSI

Intervention Type: PROCEDURE

In PICSI, the sperm is selected via hyaluronic binding before insemination into the cytoplasm of the oocyte.

Interventions

ICSI

In ICSI, the sperm is chosen based on motility and gross morphology to be inseminated directly into the cytoplasm of the oocyte.

Intervention Type: PROCEDURE

PICSI

In PICSI, the sperm is selected via hyaluronic binding before insemination into the cytoplasm of the oocyte.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Women with diminished ovarian reserves (AMH <1.2ng/ml) or severe endometriosis (rAFS Stage III or IV)
• Male partner with severe oligoasthenoteratozoospermia (Density < 5 million, Total motility < 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 or secondary to patient choice

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerry Chan, MB BCh BaO MA FRCOG PhD

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2021/RM/001

Identifier Type: -

Identifier Source: org_study_id