Clinical trial NCT06243926: Sperm Selection by Rheotaxis and Thermotaxis in In-Situ Handmade Microfluidics of Fluidic Walls in the Same ICSI Plate
Official title: Clinical Outcomes Following the Sperm Selection by Rheotaxis and Thermotaxis in In-Situ Hand-made Microfluidics of Fluidic Walls in the Same ICSI Plate: a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracytoplasmic Sperm Injection
Sperm
Microfluidics
Keywords: ICSI
Sperm Selection
Microfluidics
Assisted Reproduction Techniques
Lead sponsor: CREA Medicina de la Reproducción SL
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Couples enrolled in our IVF program, who meet the inclusion/exclusion criteria described above

Brief summary: Microfluidics technologies are proving their capability to select suitable sperm for ICSI, especially those that take advantage of the rheotaxic properties of sperm migration. In contrast to other sperm preparation methods such as Wash-Swim-Up and Density- Gradients-Centrifugation (DGC), microfluidics disregards washing and centrifugation steps along the procedure. However, microfluidics devices are costly and likely to fail to select motile sperm in dispermic samples. The investigators have recently described a novel approach for sperm selection by In-Situ handmade rheotaxis microfluidics of fluidic walls in the same ICSI plate. This methodology integrates a swim-over based on horizontal migration with a positive rheotaxis zone. The present study aims to deliver an unbiased comparison between two sperm selection techniques: DGC and In-Situ handmade rheotaxis microfluidics of fluidic walls (isM).

Detailed description: Microfluidics technologies stand as the latest sperm selection methodology for ICSI. Increasingly, publications show novel and ingenious microfluidics strategies to integrate sperm biomimicry during in vitro sperm selection while simplifying the IVF workflow. Microfluidics are time-efficient methods which reduce the risks associated with handling, gamete mix-up and ROS production. However, microfluidics devices are costly and likely to fail to select motile sperm in dispermic samples. Aiming to outline the application of microfluidics in ART, the investigators conceived a lab-on-a-chip approach for sperm selection by In-Situ rheotaxis handmade microfluidics of fluidic walls. This microfluidics system allows selecting sperm for ICSI in the same ICSI-dish. Thus, from a microvolume of the raw semen sample, only using microfluidics, disregarding centrifugation, washing, plasticware, other cells, products or materials, and using the same culture medium needed to prepare the rest of the ICSI plate.

A previous proof-of-concept study showed that this methodology efficiently selected suitable sperm for ICSI. The investigators also demonstrated that the microfluidic protocol effectively separates at least 20 progressive spermatozoa in less than 15 minutes in a clean microdroplet, free of any remaining seminal plasma. A subsequent non-inferiority study showed that the microfluidic method performs as well as density gradient centrifugation to achieve ICSI outcomes such as fertilization and day-5 blastocyst formation rate, proving that In-Situ handmade rheotaxis microfluidics of fluidic walls are also effective in supporting pre-implantation embryonic development in vitro.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing ICSI
* Female age under 40 years old
* Number of mature oocytes (MII) upon oocyte retrieval ≥ 6
* Male age under 50 years old
* Total number of progressive sperm ≥ 1 million

Exclusion Criteria:

* Patients with surgically retrieved sperm for ICSI
* Cases using cryopreserved oocytes
* Cases using cryopreserved sperm

Primary outcomes:
measure: Fertilization Rate (FR)
timeFrame: 16 to 20 hours post-ICSI (day 1)
measure: Day 5 usable blastocyst rate (D5UBR)
timeFrame: 108 to 113 hours post-ICSI (day 5)
measure: Blastocyst quality grade
timeFrame: 108 to 113 hours post-ICSI (day 5)
Secondary outcomes:
measure: Morphokinetics profile (MK PNa)
timeFrame: from 16 to 20 hours post-ICSI (day 1)
measure: Morphokinetics profile (MK PNf)
timeFrame: from 24 to 25 hours post-ICSI (day 1)
measure: Morphokinetics profile (MK t2)
timeFrame: from 24 to 28 hours post-ICSI (day 1)
measure: Morphokinetics profile (MK t4)
timeFrame: from 37 to 41hours post-ICSI (day 2)
measure: Morphokinetics profile (MK t8)
timeFrame: from 51 to 69 hours post-ICSI (day 3)
measure: Morphokinetics profile (MK tM)
timeFrame: from 81 to 96 hours post-ICSI (day 4)
measure: Morphokinetics profile (MK tSB)
timeFrame: from 99 to 101 hours post-ICSI (day 5)
measure: Morphokinetics profile (MK tB)
timeFrame: from 108 to 113 hours post-ICSI (day 5)
measure: Implantation Rate (IR)
timeFrame: 5 to 6 gestational weeks
measure: Ongoing clinical pregnancy Rate (OCP)
timeFrame: 6 to 8 gestational weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: CREA Medicina de la Reproducción
Study officials:
affiliation: CREA. Medicina de la Reproducción S.L.
name: Miguel Ruiz-Jorro MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: