Infertility, IVF
Conditions
Keywords
PICSI
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.
Interventions
PROCEDUREPICSI
In PICSI, the sperm is selected via hyaluronic binding before insemination into the cytoplasm of the oocyte.
PROCEDUREICSI
In ICSI, the sperm is chosen based on motility and gross morphology to be inseminated directly into the cytoplasm of the oocyte.
Sponsors
KK Women's and Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Trial participants, research team collecting data outcome, and all study team members except the embryologists will be blinded to treatment allocation. It is not possible to conceal allocation to the embryologists, who will perform the intervention.
Intervention model description
Participants will be randomised to undergo PICSI or standard ICSI in a 1:1 treatment ratio.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORJerry Chan, MB BCh BaO MA FRCOG PhD
KK Women's and Children's Hospital
Outcome results
None listed