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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Sperm Preparation | Active Comparator | Sperm samples in the control group will undergo traditional processing in the lab prior to insemination. |
|
| HyperSperm | Experimental | Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Sperm Preparation | Device | Standard sperm preparation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Euploidy Rate | Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle. | From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | Proportion of subjects with a clinical pregnancy, defined as the presence of an intrauterine gestational sac detected by ultrasound. | 5-7 weeks of gestation following embryo transfer. |
| Fertilization Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing Pregnancy Rate | Proportion of pregnancies progressing beyond the first trimester without pregnancy loss. | Up to 12-14 weeks of gestation. |
| Live Birth Rate | Proportion of pregnancies resulting in the birth of a live neonate. |
Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariano G Buffone, PhD | Contact | +54114783 2869 | +1314 | buffone@fecundis.com |
| Name | Affiliation | Role |
|---|---|---|
| Mariano G Buffone, PhD | Fecundis Lab SL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IFER | Buenos Aires | Buenos Aires F.D. | 1115 | Argentina |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| HyperSperm |
| Device |
Multi-step sperm preparation |
|
Proportion of oocytes successfully fertilized following insemination during IVF.
| Approximately 16-20 hours after insemination. |
| Cleavage Rate | Proportion of fertilized embryos progressing to the cleavage stage. | Day 2-3 after fertilization. |
| Blastocyst Formation Rate | Proportion of embryos that develop to the blastocyst stage. | Day 5-6 after fertilization. |
| Embryo Quality at Cleavage Stage | Embryo quality assessed according to standard morphological criteria at the cleavage stage. | Day 3 after fertilization. |
| Embryo Quality at Blastocyst Stage | Embryo quality assessed according to standard morphological criteria at the blastocyst stage. | 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. | Approximately 10-14 days after embryo transfer. |
| Progressive Motile Sperm Count After Processing | Number of progressively motile spermatozoa present after sperm processing. | 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. | Immediately after sperm processing on the day of oocyte retrieval. |
| Progressive Sperm Motility After Processing | Percentage of spermatozoa exhibiting progressive motility after sperm processing. | Immediately after sperm processing on the day of oocyte retrieval. |
| At delivery. Approximately 38-42 weeks after embryo transfer. |
| Neonatal Sex Distribution | Sex of neonates born from pregnancies resulting from the study. | At birth. Approximately 38-42 weeks after embryo transfer. |
| Birth Weight | Birth weight of neonates resulting from pregnancies in the study. | At birth. Approximately 38-42 weeks after embryo transfer. |
| Gestational Age at Birth | Gestational age of the neonate at the time of delivery. | At birth. Approximately 38-42 weeks after embryo transfer. |
| Mode of Delivery | Type of delivery, categorized as vaginal delivery or cesarean section. | 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. | 5-7 weeks of gestation. |
| Spontaneous Abortion Rate | Proportion of pregnancies resulting in spontaneous pregnancy loss before 20 weeks of gestation. | 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. | 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. | 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. | 6 and 12 months of age. |
| Achievement of Developmental Milestones | Assessment of age-appropriate developmental milestones during pediatric follow-up visits. | 6 and 12 months of age. |
| Congenital Anomalies | Number of infants diagnosed with congenital anomalies during the follow-up period. | From birth up to 12 months of age. |
| Pregna | Buenos Aires | Buenos Aires F.D. | 1425 | Argentina |