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CompletedNCT04159402Updated Oct 4, 2022

Dissect Assembly Rules of SPET12 Complex in the Mammalian Sperm

An observational study in Spermatozoa and Fertility, sponsored by National Cheng-Kung University Hospital. Completed. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-04.

Sponsored by National Cheng-Kung University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
183
Ages
20 Years to 50 Years
Sex
Male
01

Study summary

The sperm of the KO mouse shothe investigatorsd severe defects of all found compartments: acrosome, nucleus, midpiece and tail. The investigators also found SEPT12 co-localizes and interact with SEPT1, 2, 4, 6, 7, 10, 11, and 14 in sperm. Interestingly, some of these septins form filaments with SEPT12 in cells. Based on these findings, it is hypothesized that (1) The core complex of SEPT12 filament consists of SEPT12-7-6-2-2-6-7-12; (2) Septin12 mutations, genetic variants, as the investigatorsll as haploinsufficiency disrupt SEPT12 filament and macro-complex; (3) Other SEPT's (e.g. SETP4, SEPT14) are also involved in the functionality of SEPT12; and (4) SEPT12 macro-complex is critical for compartment formation during terminal differentiation of male germ cells. The proposed study is designed to confirm the above hypotheses, to deconstruct mammalian SEPT12 complex, and to elucidate the functional significance of Septin12 mutations. In the proposed study, the investigators will use different methods, including proteomics, immunofluorescence assay, co- immunoprecipitation, pull-down assay, protein domain mapping, and protein complex fractionation to test the above hypothesis. The investigators have created a mouse carrying an important Septin12 mutation. In the proposed study, the investigators plan to knock out Septin14 in the mouse. SEPT14 interacts with SEPT12 and is also predominantly expressed in sperm. The mouse models and research tools could be used to explore the role of septins during spermiogenesis, to deconstruct the SEPT12 complex in the mammalian sperm, and to elucidate the functional significance of the Septin 12 mutations. Our findings may provide novel insight into the pathways human spermatogenesis, and has the potential to lead to development of therapeutic models for male infertility, and design of male contraceptives.

Read the detailed description

Redundancy and Interchangeability of Septins Septins 3, 4, 5, 6, 11, and 12 have been knocked out in the mouse model. Although SEPT4 abundantly expressed in different tissues, Septin4 KO mice only shothe investigatorsd male reproductive failure. SEPT12 is exclusively expressed in the post-meiotic germ cells, and Septin12+/- KO mice shothe investigatorsd spermatogenetic failure. In one study, SEPT5 deficiency decreased anxiety-related behavior, increased prepulse inhibition and delayed acquisition of rewarded goal approach, independent of mouse genetic backgrounds. In another study, Septin3-/- and Septin5-/-mice did not show any overt phenotypes. Knockout of a ubiquitously expressed septin, Septin6, also did not result in abnormal phenotypes. SETP11 is ubiquitously expressed, and Sept11 null mutation died in utero. The findings suggest redundancy and interchangeability of many septin family members. Among the septin family members, SEPT12 and 14 may deserve special attention for the reproductive biologists because they are mainly expressed in the testis.

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Conditions studied

  • Spermatozoa
  • Fertility
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In context

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The participants were clinically diagnosed by semen analysis and further collected the normal human sperm.

Inclusion criteria

  • All participants signed a written informed consent form.
  • Semen samples were obtained by masturbation after 3-5 days of sexual abstinence.

Exclusion criteria

exclusion criteria:

.None

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
183 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Losses of SEPT12, SEPT7, SEPT6, SEPT2 and SEPT4 from the sperm annulus of a SEPT12D197N patient.

    Immunofluorescence staining of normal sperm in a fertile control showed signals for SEPT12 . SEPT7, SEPT6, SEPT2 and SEPT4 (red) at the annulus. Also shown are merged fluorescence staining images with the additional staining of the sperm nuclei, as well as merged fluorescence staining images with merged brightfield images (BF merged). Blue color, DAPI stain; BF, brightfield only. Scale bar: 10 µm.

    Time frame: 1 day

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04159402
Lead sponsor
National Cheng-Kung University Hospital
Responsible party
Sponsor
First posted
Nov 12, 2019
Start date
Aug 2014
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Oct 4, 2022

Study contacts

Pao-Lin Kuo, MD
principal investigator · Department of Obstetrics and Gynecology, National Cheng Kung University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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