AzTrials
AzTrials

Male InfertilityNCT06545318

A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches

A study testing Density Gradient Centrifugation and CA0 chamber in people with Male Infertility, run by Center of Innovation Technology & Reproductive Medicine at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to know if a novel sperm selection device (CA0) has a similar performance than the standard selection method in teratozoospermic and azoospermic men. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Male Infertility
What is being tested?
Density Gradient Centrifugation and CA0 chamber
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteMexico
Study dates
1 Jan 2023to 15 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Normozoospermic (18-35 years old) and teratozoospermic (18-60 years old) patients undergoing IVF/ICSI cyles with at least 2 days of sexual abstinence

Who cannot join

  • Less than 4 oocytes collected during oocyte retrieval
  • Total sperm count less than 30x10^6

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • CITMER

    Mexico City, 11520

Other trials in Mexico

About this study

Official title: A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches: Validation Through a Clinical Pilot Study

The goal of this clinical trial is to know if a novel sperm selection device (CA0) has a similar performance than the standard selection method in teratozoospermic and azoospermic men. The main questions it aims to answer are:

Does the CA0 sperm selection device increases the sperm concentration? Does the CA0 sperm selection device increases the sperm motility? What are the differences in sperm membrane potential when CA0 is used? Do intracellular Calcium levels change when CA0 is used? Does CA0 increase fertilization rates? Researchers will compare CA0 to the standard of care for sperm selection (density gradient centrifugation) to see if CA0 has similar performance

Read more

Participants will:

Provide a semen sample Have their semen sample analyzed, processed and used for assisted reproduction technologies

Being tested
Density Gradient Centrifugation, CA0 chamber
Keywords
Spem preparation, in vitro fertilization, Sperm membrane potential, Sperm intracellular calcium
Medical subject headings
Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Density Gradient CentrifugationDevice

    Sperm separation with density gradients

  • CA0 chamberDevice

    Sperm separation with a novel device

Study groups in NCT06545318
Study groupRoleWhat they receive
Density Gradient CentrifugationActive comparatorA density gradient of is formed in 15 mL conical tubes as follows: 1 mL of lower gradient (90%) medium is placed at the bottom, 1 mL of upper (45%) gradient medium is placed on top of the bottom layer, and 1 mL of semen sample is layered above the gradient. Tubes are centrifuged for 10 minutes at 1,200 x g at room temperature. The pellet containing the viable cells is separated, resuspended in 1 mL of HTF-HEPES medium, and centrifuged at room temperature for 10 minutes at 1,200 x g to remove traces of gradient medium. The supernatant is then removed, 500 µL of HTF-HEPES medium are added to the sperm pellet, carefully mixed, and cells are counted
Receives: Device: Density Gradient Centrifugation
CA0 chamberExperimentalOne mL of semen is placed in the base, then the intermediate part is placed on the base, taking care to match the notches that assemble both parts. Subsequently, 900 µL of HTF-HEPES medium are placed in the intermediate part, the cover is placed and the device is incubated at 37°C for 30 minutes. Subsequently, a 500-µL aliquot is recovered and cells are counted
Receives: Device: CA0 chamber

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sperm membrane potential

    Evaluation of the KCl-induced difference of membrane potential voltage in mV, after sperm selection.

    Measured: Within 2 hours from the sperm collection

  2. Sperm intracellular Calcium

    Evaluation of the progesterone-induced intracellular calcium fluorescent peaks after sperm selection

    Measured: Within 2 hours from the sperm collection

  3. Sperm concentration

    Assessment of sperm count after sperm separation

    Measured: Within 2 hours from the sperm collection

  4. Sperm motility

    Percentage of progresive, non-progressive and immotile sperm after sperm separation

    Measured: Within 2 hours from the sperm collection

  5. Fertilization rates

    Determination of the rate of 2 pronucleous, 2 polar bodies zygotes after insemination

    Measured: 17-20 hours after insemination by IVF or ICSI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start1 Jan 2023
  3. Primary completion30 Oct 2023
  4. Study completion15 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06545318
Sponsor's protocol ID
CI-21-101
Status last verified
Aug 2024
First submitted
22 Jul 2024
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Share all IPD that underlie results in the resulting publications

Publications

  • Allamaneni SS, Agarwal A, Rama S, Ranganathan P, Sharma RK. Comparative study on density gradients and swim-up preparation techniques utilizing neat and cryopreserved spermatozoa. Asian J Androl. 2005 Mar;7(1):86-92. doi: 10.1111/j.1745-7262.2005.00008.x.

    PubMed 15685358

  • Babcock DF. Examination of the intracellular ionic environment and of ionophore action by null point measurements employing the fluorescein chromophore. J Biol Chem. 1983 May 25;258(10):6380-9.

    PubMed 6853488

  • Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.

    PubMed 21502182

  • Brown SG, Publicover SJ, Mansell SA, Lishko PV, Williams HL, Ramalingam M, Wilson SM, Barratt CL, Sutton KA, Da Silva SM. Depolarization of sperm membrane potential is a common feature of men with subfertility and is associated with low fertilization rate at IVF. Hum Reprod. 2016 Jun;31(6):1147-57. doi: 10.1093/humrep/dew056. Epub 2016 Apr 6.

    PubMed 27052499

  • Chen MJ, Bongso A. Comparative evaluation of two density gradient preparations for sperm separation for medically assisted conception. Hum Reprod. 1999 Mar;14(3):759-64. doi: 10.1093/humrep/14.3.759.

    PubMed 10221710

  • Farland LV, Khan SM, Missmer SA, Stern D, Lopez-Ridaura R, Chavarro JE, Catzin-Kuhlmann A, Sanchez-Serrano AP, Rice MS, Lajous M. Accessing medical care for infertility: a study of women in Mexico. F S Rep. 2022 Nov 24;4(1):112-120. doi: 10.1016/j.xfre.2022.11.013. eCollection 2023 Mar.

    PubMed 36959957

  • Henkel RR, Schill WB. Sperm preparation for ART. Reprod Biol Endocrinol. 2003 Nov 14;1:108. doi: 10.1186/1477-7827-1-108.

    PubMed 14617368

  • Hernandez-Silva G, Lopez-Torres AS, Maldonado-Rosas I, Mata-Martinez E, Larrea F, Torres-Flores V, Trevino CL, Chirinos M. Effects of Semen Processing on Sperm Function: Differences between Swim-Up and Density Gradient Centrifugation. World J Mens Health. 2021 Oct;39(4):740-749. doi: 10.5534/wjmh.200115. Epub 2020 Nov 19.

    PubMed 33474848

  • Highland HN, Rishika AS, Almira SS, Kanthi PB. Ficoll-400 density gradient method as an effective sperm preparation technique for assisted reproductive techniques. J Hum Reprod Sci. 2016 Jul-Sep;9(3):194-199. doi: 10.4103/0974-1208.192070.

    PubMed 27803588

  • Hsu CT, Lee CI, Lin FS, Wang FZ, Chang HC, Wang TE, Huang CC, Tsao HM, Lee MS, Agarwal A. Live motile sperm sorting device for enhanced sperm-fertilization competency: comparative analysis with density-gradient centrifugation and microfluidic sperm sorting. J Assist Reprod Genet. 2023 Aug;40(8):1855-1864. doi: 10.1007/s10815-023-02838-4. Epub 2023 Jun 10.

    PubMed 37300647

  • Matamoros-Volante A, Castillo-Viveros V, Torres-Rodriguez P, Trevino MB, Trevino CL. Time-Lapse Flow Cytometry: A Robust Tool to Assess Physiological Parameters Related to the Fertilizing Capability of Human Sperm. Int J Mol Sci. 2020 Dec 24;22(1):93. doi: 10.3390/ijms22010093.

    PubMed 33374265

Questions about this trial

What is this clinical trial studying?

A study testing Density Gradient Centrifugation and CA0 chamber in people with Male Infertility, run by Center of Innovation Technology & Reproductive Medicine at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sperm membrane potential (time frame: Within 2 hours from the sperm collection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06545318, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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