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

Infertility Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05017740
• Other study ID #: 2021/RM/001
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: KK Women's and Children's Hospital
• Contact: Xiang Wen Ng, MPH
• Phone: +65 63948113
• Email: ng.xiang.wen[@]kkh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• IVF

Intervention

Procedure:
• ICSI
In ICSI, the sperm is chosen based on motility and gross morphology to be inseminated directly into the cytoplasm of the oocyte.
• PICSI
In PICSI, the sperm is selected via hyaluronic binding before insemination into the cytoplasm of the oocyte.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Miscarriage rate	Pregnancy loss before 23+6 completed weeks after confirmation of clinical pregnancy	6 to 23+6 gestational weeks
Secondary	Fertilisation rate	Successful embryo transfer	2-5 days after oocyte retrieval
Secondary	Live birth rate	Live birth after 24 completed weeks of gestation	After 24 completed weeks of gestation