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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
47
KK Women's and Children's Hospital
Singapore, Singapore
Clinical pregnancy rate
The presence of fetal heartbeat or gestational sac at 6-9 weeks after fresh embryo transfer
Time frame: 6-9 weeks after fresh embryo transfer
Miscarriage rate
Pregnancy loss before 23+6 completed weeks after confirmation of clinical pregnancy
Time frame: 6 to 23+6 gestational weeks
Fertilisation rate
Successful embryo transfer
Time frame: 2-5 days after oocyte retrieval
Live birth rate
Live birth after 24 completed weeks of gestation
Time frame: After 24 completed weeks of gestation
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