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

NCT05017740 | Active Not Recruiting

• 1 other identifier: 2021/RM/001
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Keywords

PICSI

Outcome Measures

Primary Outcomes (2)

• Clinical pregnancy rate

  The presence of fetal heartbeat or gestational sac at 6-9 weeks after fresh embryo transfer

  6-9 weeks after fresh embryo transfer

• Miscarriage rate

  Pregnancy loss before 23+6 completed weeks after confirmation of clinical pregnancy

  6 to 23+6 gestational weeks

Secondary Outcomes (2)

• Fertilisation rate

  2-5 days after oocyte retrieval

• Live birth rate

  After 24 completed weeks of gestation

Study Arms (2)

ICSI

ACTIVE COMPARATOR

Procedure: ICSI

PICSI

ACTIVE COMPARATOR

Procedure: PICSI

Interventions

ICSI PROCEDURE

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

ICSI

PICSI PROCEDURE

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

PICSI

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Jerry Chan, MB BCh BaO MA FRCOG PhD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Trial participants, research team collecting data outcome, and all study team members except the embryologists will be blinded to treatment allocation. It is not possible to conceal allocation to the embryologists, who will perform the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomised to undergo PICSI or standard ICSI in a 1:1 treatment ratio.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: March 15, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)