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.

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; IVF
• Intervention / Treatment: Procedure: ICSI; Procedure: PICSI

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang Wen Ng, MPH; Phone Number: +65 63948113; Email: ng.xiang.wen@kkh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • Recruiting
    • KK Women's and Children's Hospital
    • Contact: Xiang Wen Ng, MPH; Phone Number: +65-63948113; Email: Ng.Xiang.Wen@kkh.com.sg
    • Principal Investigator: Shu Qi Tan, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ICSI	Procedure: ICSI; In ICSI, the sperm is chosen based on motility and gross morphology to be inseminated directly into the cytoplasm of the oocyte.
Active Comparator: PICSI	Procedure: PICSI; In PICSI, the sperm is selected via hyaluronic binding before insemination into the cytoplasm of the oocyte.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilisation rate	Successful embryo transfer	2-5 days after oocyte retrieval
Live birth rate	Live birth after 24 completed weeks of gestation	After 24 completed weeks of gestation

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Shu Qi Tan, MBBS, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: PICSI
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 2021/RM/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No