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

February 5, 2024 updated by: CREA Medicina de la Reproducción SL

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46003
        • Recruiting
        • CREA Medicina de la Reproducción
        • Contact:
        • Principal Investigator:
          • Miguel Ruiz-Jorro, PhD
        • Sub-Investigator:
          • Minerva Ferrer-Buitrago, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Sperm capacitation
  • Sperm sorting
  • Sperm separation
  • Sperm recovery
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
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.
Other Names:
  • Sperm capacitation
  • Sperm sorting
  • Sperm separation
  • Sperm recovery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization Rate (FR)
Time Frame: 16 to 20 hours post-ICSI (day 1)
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)
Time Frame: 108 to 113 hours post-ICSI (day 5)
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
Time Frame: 108 to 113 hours post-ICSI (day 5)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphokinetics profile (MK PNa)
Time Frame: from 16 to 20 hours post-ICSI (day 1)
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)
Morphokinetics profile (MK PNf)
Time Frame: from 24 to 25 hours post-ICSI (day 1)
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)
Morphokinetics profile (MK t2)
Time Frame: from 24 to 28 hours post-ICSI (day 1)
The proportion of embryos showing 2 cells (t2) out of the expected time frame.
from 24 to 28 hours post-ICSI (day 1)
Morphokinetics profile (MK t4)
Time Frame: from 37 to 41hours post-ICSI (day 2)
The proportion of embryos showing 4 cells (t4) out of the expected time frame.
from 37 to 41hours post-ICSI (day 2)
Morphokinetics profile (MK t8)
Time Frame: from 51 to 69 hours post-ICSI (day 3)
The proportion of embryos showing 8 cells (t8) out of the expected time frame.
from 51 to 69 hours post-ICSI (day 3)
Morphokinetics profile (MK tM)
Time Frame: from 81 to 96 hours post-ICSI (day 4)
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)
Morphokinetics profile (MK tSB)
Time Frame: from 99 to 101 hours post-ICSI (day 5)
The proportion of embryos starting to blastulate (tSB) out of the expected time frame.
from 99 to 101 hours post-ICSI (day 5)
Morphokinetics profile (MK tB)
Time Frame: from 108 to 113 hours post-ICSI (day 5)
The proportion of embryos starting to blastulate (tB) out of the expected time frame.
from 108 to 113 hours post-ICSI (day 5)
Implantation Rate (IR)
Time Frame: 5 to 6 gestational weeks
The proportion of embryos that were transferred that develop to a gestational sac
5 to 6 gestational weeks
Ongoing clinical pregnancy Rate (OCP)
Time Frame: 6 to 8 gestational weeks
The proportion of embryos that were transferred that develop at least to the stage of fetal heart activity
6 to 8 gestational weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CREA Medicina de la Reproducción SL

Investigators

  • Principal Investigator: Miguel Ruiz-Jorro MD, MSc, PhD, CREA. Medicina de la Reproducción S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Estimated)

February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • e.23.I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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