An observational study in Spermatozoa, Abnormal, in Vitro Fertilization and Blastocyst, sponsored by Calla IVF Center. Completed at 1 site in Romania. Open to participants aged 21 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Calla IVF Center · Observational
Samples from male partners of 120 infertile couples undergoing IVF were analyzed. Sperm morphology was assessed using the SpermBlue staining method, while TZI, MAI, and SDI were calculated. Embryo development was monitored until day 5 or 6. Statistical analyses included regression models and correlation coefficients to evaluate the predictive value of sperm indices on blastocyst development.
For spermatozoa selection we used ZyMot multi in all patients undergoing IVF. After intracytoplasmatic injection of spermatozoa we asses the blastocyst grading in day 5. NEQSI score meaning numerical embryonic quality score index was used for statistical purpose. The spermatozoa morphology indexes were: TZI (teratozoospermia index), MAI (multiple anomalies index), SDI (sperm deformity index) and analyzed with CASA analyzer. All these indexes were assessed in patients and correlated in all groups: patients that had a positive pregnancy test, patients that had a negative pregnancy rate, patients that had no blastocyst in day 5 and patients that had all aneuploid embyos.
73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.
This study's enrollment of 120 is below the median of 325 across 38 observational studies indexed under Aneuploidy.
Browse Aneuploidy studies →Calla IVF Center is the lead sponsor of 4 studies on the registry; none are open to participants now.
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This prospective observational study analyzed sperm and embryonic parameters from 120 IVF cycles over 18 months. Functional sperm indices and embryo outcomes were evaluated to determine their relationship.
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Exclusion Criteria:
Patients with sperm morphology indexes analyzed and had at least one good quality blastocyst that had a Positive HCG pregnancy test after embryo-transfer.
Other: Sperm morphology indexes
Patients with sperm morphology indexes analyzed and had at least one good quality blastocyst that had a Negative HCG pregnancy test after embryo-transfer.
Other: Sperm morphology indexes
Patients with sperm morphology indexes analyzed and had no blastocyst in day 5 or 6 after ICSI-IVF.
Other: Sperm morphology indexes
Patients with sperm morphology indexes analyzed and had all blastocyst of day 5/6 tested and aneuployd after ICSI-IVF.
Other: Sperm morphology indexes
We analyzed all sperm morphology indexes in all groups.
Evaluation of sperm morphology indices on fertilization and blastulation rate
Functional sperm indices and embryo outcomes were evaluated to determine their relationship.
Time frame: 18 months
Evaluation of sperm morphology indices on IVF outcomes
The study's findings are limited to IVF populations and may not generalize to natural conception.
Time frame: 16 months
Ran from Oct 2023 to primary completion in Oct 2024, 12 months.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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