Clinical trial NCT05017740: PICSI RCT in Couples With a Previous Poor Fertilisation Cycle in IVF
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infertility
IVF
Keywords: PICSI
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2021-08-24
Enrollment: 47
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised to undergo PICSI or standard ICSI in a 1:1 treatment ratio.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6-9 weeks after fresh embryo transfer
measure: Miscarriage rate
timeFrame: 6 to 23+6 gestational weeks
Secondary outcomes:
measure: Fertilisation rate
timeFrame: 2-5 days after oocyte retrieval
measure: Live birth rate
timeFrame: After 24 completed weeks of gestation
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Shu Qi Tan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: