The Influence of Sperm Morphology and Functional Indices on Blastocyst Development in Assisted Reproduction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06801652

Enrollment

120

Registered

2025-01-30

Start date

2023-10-21

Completion date

2024-11-10

Last updated

2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneuploidy, Blastocyst, in Vitro Fertilization, Spermatozoa, Abnormal

Brief summary

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.

Detailed description

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.

Interventions

OTHERSperm morphology indexes

We analyzed all sperm morphology indexes in all groups.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 40 Years

Inclusion criteria

* couples with an infertility diagnosis that underwent an IVF procedure and had obtained at least one blastocyst

Exclusion criteria

* donors * uterine abnormalities

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of sperm morphology indices on fertilization and blastulation rate	18 months	Functional sperm indices and embryo outcomes were evaluated to determine their relationship.

Secondary

Measure	Time frame	Description
Evaluation of sperm morphology indices on IVF outcomes	16 months	The study's findings are limited to IVF populations and may not generalize to natural conception.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026