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Efficacy and Safety of a New Sperm Capacitation Method

Study acronym: HyperSperm01
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jun 2026 → Sep 2026
See other at-risk trials from Fecundis Lab SL

Record History

  1. Primary and study completion pushed from Jun 2026 to Sep 2026v5
  2. Primary and study completion dates: Dec 2025 to Jun 2026v4
  3. Site details revised at 4 of 4 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2024 to Jan 14, 2025
    • Site details revised at 4 of 4 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.
Trial Details
NCT Number NCT06742437
Lead Sponsor Fecundis Lab SL
Conditions
(from sponsor)		 Reproductive Issues, Male Infertility, Asthenozoospermia, Oligozoospermia, Teratozoospermia
Related terms Asthenozoospermia, Infertility, Male, Oligospermia, Teratozoospermia
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov