Sperm Selection by Rheotaxis and Thermotaxis in In-Situ Handmade Microfluidics of Fluidic Walls in the Same ICSI Plate

Intracytoplasmic Sperm Injection Clinical Trial

— IS-MFluidics  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243926
• Other study ID #: e.23.I
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: CREA Medicina de la Reproducción SL
• Contact: Minerva Ferrer-Buitrago, BSc, PGDip, PhD
• Phone: +34622342562
• Email: minerva.ferrer[@]creavalencia.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracytoplasmic Sperm Injection
• Sperm

Intervention

Other:
• Sperm selection for ICSI
Sperm selection for ICSI is a critical step to ensure the use of viable and healthy sperm for fertilization in vitro. The goal is to choose a sperm that has the best chance of resulting in a successful pregnancy.

Locations

Country	Name	City	State
Spain	CREA Medicina de la Reproducción	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
CREA Medicina de la Reproducción SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization Rate (FR)	The proportion of two-pronuclei zygote divided by the total number of matured and microinjected oocytes (2pn/MII, %)	16 to 20 hours post-ICSI (day 1)
Primary	Day 5 usable blastocyst rate (D5UBR)	The proportion of embryos classified as blastocysts at day 5 of development, which has been transferred and/or cryopreserved.	108 to 113 hours post-ICSI (day 5)
Primary	Blastocyst quality grade	Blastocysts are categorized following the scale described by the Spanish Association of Reproduction Biology Studies (ASEBIR). The ASEBIR classification categorizes blastocysts based on their morphology into four groups: from A (highest, better outcome) to D (lowest, worse outcome).	108 to 113 hours post-ICSI (day 5)
Secondary	Morphokinetics profile (MK PNa)	The proportion of embryos showing the appearance of pronuclei (PNa) out of the expected time frame.	from 16 to 20 hours post-ICSI (day 1)
Secondary	Morphokinetics profile (MK PNf)	The proportion of embryos showing the fading of pronuclei (PNf) out of the expected time frame.	from 24 to 25 hours post-ICSI (day 1)
Secondary	Morphokinetics profile (MK t2)	The proportion of embryos showing 2 cells (t2) out of the expected time frame.	from 24 to 28 hours post-ICSI (day 1)
Secondary	Morphokinetics profile (MK t4)	The proportion of embryos showing 4 cells (t4) out of the expected time frame.	from 37 to 41hours post-ICSI (day 2)
Secondary	Morphokinetics profile (MK t8)	The proportion of embryos showing 8 cells (t8) out of the expected time frame.	from 51 to 69 hours post-ICSI (day 3)
Secondary	Morphokinetics profile (MK tM)	The proportion of embryos with full cell compaction (morula; tM) out of the expected time frame.	from 81 to 96 hours post-ICSI (day 4)
Secondary	Morphokinetics profile (MK tSB)	The proportion of embryos starting to blastulate (tSB) out of the expected time frame.	from 99 to 101 hours post-ICSI (day 5)
Secondary	Morphokinetics profile (MK tB)	The proportion of embryos starting to blastulate (tB) out of the expected time frame.	from 108 to 113 hours post-ICSI (day 5)
Secondary	Implantation Rate (IR)	The proportion of embryos that were transferred that develop to a gestational sac	5 to 6 gestational weeks
Secondary	Ongoing clinical pregnancy Rate (OCP)	The proportion of embryos that were transferred that develop at least to the stage of fetal heart activity	6 to 8 gestational weeks