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

Not Applicable

Active, not recruiting

• Conditions: Infertility; IVF
• Interventions: Procedure: PICSI; Procedure: ICSI

• Registration Number: NCT05017740
• Lead Sponsor: KK Women's and Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Study Start: 2022-03-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICSI	PICSI	-
ICSI	ICSI	-

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6-9 weeks after fresh embryo transfer	The presence of fetal heartbeat or gestational sac at 6-9 weeks after fresh embryo transfer
Miscarriage rate	6 to 23+6 gestational weeks	Pregnancy loss before 23+6 completed weeks after confirmation of clinical pregnancy

Secondary Outcome Measures

Name	Time	Method
Fertilisation rate	2-5 days after oocyte retrieval	Successful embryo transfer
Live birth rate	After 24 completed weeks of gestation	Live birth after 24 completed weeks of gestation

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore