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

NCT06243926 | Recruiting

• 1 other identifier: e.23.I
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Intracytoplasmic Sperm Injection; Sperm; Microfluidics

Keywords

ICSI; Sperm Selection; Microfluidics; Assisted Reproduction Techniques

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (10)

• Morphokinetics profile (MK PNa)

  from 16 to 20 hours post-ICSI (day 1)

• Morphokinetics profile (MK PNf)

  from 24 to 25 hours post-ICSI (day 1)

• Morphokinetics profile (MK t2)

  from 24 to 28 hours post-ICSI (day 1)

• Morphokinetics profile (MK t4)

  from 37 to 41hours post-ICSI (day 2)

• Morphokinetics profile (MK t8)

  from 51 to 69 hours post-ICSI (day 3)

Study Arms (2)

Density gradient centrifugation (DGC)

DGC is a protocol to select sperm based on their density and isopycnic points. It is a conventional protocol commonly used in IVF laboratories.

Other: Sperm selection for ICSI

In-Situ rheotaxis handmade microfluidics (isM)

The isM is a novel protocol to select sperm for ICSI based on microfluidics and sperm guidance responses to rheotaxis and thermotaxis. The isM protocol proved its efficacy and effectivity for ICSI in previous proof of concept and non-inferiority studies, respectively.

Other: Sperm selection for ICSI

Interventions

Sperm selection for ICSI OTHER

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.

Also known as: Sperm capacitation, Sperm sorting, Sperm separation, Sperm recovery

Density gradient centrifugation (DGC); In-Situ rheotaxis handmade microfluidics (isM)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Female: Age from 18 to 39 years old Number of mature oocytes (MII) upon oocyte retrieval ≥ 6 Male: Age from 18 to 49 years old Total number of progressive sperm ≥ 1 million
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Couples enrolled in our IVF program, who meet the inclusion/exclusion criteria described above

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CREA Medicina de la Reproducción SL: lead

Study Sites (1)

CREA Medicina de la Reproducción

Valencia, 46003, Spain

RECRUITING

MeSH Terms

Interventions

Sperm Injections, Intracytoplasmic; Sperm Capacitation

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Fertilization; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Miguel Ruiz-Jorro MD, MSc, PhD

  CREA. Medicina de la Reproducción S.L.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minerva Ferrer-Buitrago, BSc, PGDip, PhD

CONTACT

+34622342562; minerva.ferrer@creavalencia.com

Miguel Ruiz-Jorro, MD, MSc, PhD

CONTACT

miguel.ruiz@creavalencia.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 6, 2024
• Study Start: January 8, 2024
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)