Skip to main content
OpenTrials
Completed

NCT Number: NCT06801652

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spermatozoa, Abnormal Aneuploidy Blastocyst Chromosome Aberrations Genital Diseases Genital Diseases, Male In Vitro Fertilization Infertility Infertility, Male Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Teratozoospermia Urogenital Diseases

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Calla Ivf Center

Oradea, Bihor County, 410103, Romania

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • donors
  • uterine abnormalities

Treatment and study plan

Sperm morphology indexes

Other

We analyzed all sperm morphology indexes in all groups.

Primary outcomes

  1. Evaluation of sperm morphology indices on fertilization and blastulation rate

    Time frame: 18 months

    Functional sperm indices and embryo outcomes were evaluated to determine their relationship.

Secondary outcomes

  1. Evaluation of sperm morphology indices on IVF outcomes

    Time frame: 16 months

    The study's findings are limited to IVF populations and may not generalize to natural conception.

Sponsors and collaborators

Lead sponsor

Calla IVF Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.