An interventional study of Standard Sperm Preparation and HyperSperm in Infertility, sponsored by Fecundis Lab SL. Not yet recruiting at 2 sites in Argentina. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Fecundis Lab SL · Not applicable, Interventional, and Treatment
Prospective, multicenter, randomized clinical study evaluating the safety of a novel sperm preparation method for in vitro fertilization (IVF), compared to standard sperm preparation procedures.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 202 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Fecundis Lab SL is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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General
Female
Male
Exclusion Criteria:
General
Female
Male
- Any medical condition affecting semen quality that, in the investigator's opinion, may interfere with study participation.
Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.
Device: Standard Sperm Preparation
Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.
Device: HyperSperm
Standard sperm preparation
Multi-step sperm preparation
Euploidy Rate
Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle.
Time frame: From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).
Clinical Pregnancy Rate
Proportion of subjects with a clinical pregnancy, defined as the presence of an intrauterine gestational sac detected by ultrasound.
Time frame: 5-7 weeks of gestation following embryo transfer.
Fertilization Rate
Proportion of oocytes successfully fertilized following insemination during IVF.
Time frame: Approximately 16-20 hours after insemination.
Cleavage Rate
Proportion of fertilized embryos progressing to the cleavage stage.
Time frame: Day 2-3 after fertilization.
Blastocyst Formation Rate
Proportion of embryos that develop to the blastocyst stage.
Time frame: Day 5-6 after fertilization.
Embryo Quality at Cleavage Stage
Embryo quality assessed according to standard morphological criteria at the cleavage stage.
Time frame: Day 3 after fertilization.
Embryo Quality at Blastocyst Stage
Embryo quality assessed according to standard morphological criteria at the blastocyst stage.
Time frame: Day 5-6 after fertilization.
Biochemical Pregnancy Rate
Proportion of participants with biochemical pregnancy, defined as a detectable increase in serum β-hCG concentration following embryo transfer.
Time frame: Approximately 10-14 days after embryo transfer.
Progressive Motile Sperm Count After Processing
Number of progressively motile spermatozoa present after sperm processing.
Time frame: Immediately after sperm processing on the day of oocyte retrieval.
Total Sperm Motility After Processing
Percentage of spermatozoa showing any type of motility following sperm processing.
Time frame: Immediately after sperm processing on the day of oocyte retrieval.
Progressive Sperm Motility After Processing
Percentage of spermatozoa exhibiting progressive motility after sperm processing.
Time frame: Immediately after sperm processing on the day of oocyte retrieval.
Ongoing Pregnancy Rate
Proportion of pregnancies progressing beyond the first trimester without pregnancy loss.
Time frame: Up to 12-14 weeks of gestation.
Live Birth Rate
Proportion of pregnancies resulting in the birth of a live neonate.
Time frame: At delivery. Approximately 38-42 weeks after embryo transfer.
Neonatal Sex Distribution
Sex of neonates born from pregnancies resulting from the study.
Time frame: At birth. Approximately 38-42 weeks after embryo transfer.
Birth Weight
Birth weight of neonates resulting from pregnancies in the study.
Time frame: At birth. Approximately 38-42 weeks after embryo transfer.
Gestational Age at Birth
Gestational age of the neonate at the time of delivery.
Time frame: At birth. Approximately 38-42 weeks after embryo transfer.
Mode of Delivery
Type of delivery, categorized as vaginal delivery or cesarean section.
Time frame: At birth. Approximately 38-42 weeks after embryo transfer.
Multiple Pregnancy Rate
Proportion of pregnancies resulting in multiple gestations, defined as the presence of more than one intrauterine gestational sac detected by ultrasound.
Time frame: 5-7 weeks of gestation.
Spontaneous Abortion Rate
Proportion of pregnancies resulting in spontaneous pregnancy loss before 20 weeks of gestation.
Time frame: From confirmation of clinical pregnancy up to 20 weeks of gestation.
Neonatal Examination at Hospital Discharge
Clinical neonatal examination performed at hospital discharge to assess the overall health status of the newborn and identify any congenital anomalies.
Time frame: Within 1 week after delivery (approximately 38-43 weeks after embryo transfer).
Infant Weight at Follow-Up
Body weight of infants resulting from pregnancies in the study, measured during pediatric follow-up visits.
Time frame: 6 and 12 months of age.
Infant Length at Follow-Up
Body length of infants resulting from pregnancies in the study, measured during pediatric follow-up visits.
Time frame: 6 and 12 months of age.
Achievement of Developmental Milestones
Assessment of age-appropriate developmental milestones during pediatric follow-up visits.
Time frame: 6 and 12 months of age.
Congenital Anomalies
Number of infants diagnosed with congenital anomalies during the follow-up period.
Time frame: From birth up to 12 months of age.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Mar 2028, 15 months later.
Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 15 months is below that.
Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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