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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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IVF, Infertility

Intervention / Treatment
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* Procedure: ICSI
* Procedure: PICSI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomised to undergo PICSI or standard ICSI in a 1:1 treatment ratio.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICSI<br> | Procedure: ICSI<br>* In ICSI, the sperm is chosen based on motility and gross morphology to be inseminated directly into the cytoplasm of the oocyte.<br>|
| Active Comparator: PICSI<br> | Procedure: PICSI<br>* In PICSI, the sperm is selected via hyaluronic binding before insemination into the cytoplasm of the oocyte.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Miscarriage rate | Pregnancy loss before 23+6 completed weeks after confirmation of clinical pregnancy | 6 to 23+6 gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilisation rate | Successful embryo transfer | 2-5 days after oocyte retrieval | 
| Live birth rate | Live birth after 24 completed weeks of gestation | After 24 completed weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PICSI