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

NCT06801652 | Completed

• 1 other identifier: CALLA TERATOZOOSPERMIA
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Spermatozoa, Abnormal; in Vitro Fertilization; Blastocyst; Aneuploidy

Outcome Measures

Primary Outcomes (1)

• Evaluation of sperm morphology indices on fertilization and blastulation rate

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

  18 months

Secondary Outcomes (1)

• Evaluation of sperm morphology indices on IVF outcomes

  16 months

Study Arms (4)

Positive HCG pregnancy test after embryotransfer

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

Negative HCG pregnancy test after embryotransfer

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

No embryo obtained after IVF

Patients with sperm morphology indexes analyzed and had no blastocyst in day 5 or 6 after ICSI-IVF.

Other: Sperm morphology indexes

All embryos obtained are aneuploid

Patients with sperm morphology indexes analyzed and had all blastocyst of day 5/6 tested and aneuployd after ICSI-IVF.

Other: Sperm morphology indexes

Interventions

Sperm morphology indexes OTHER

We analyzed all sperm morphology indexes in all groups.

All embryos obtained are aneuploid; Negative HCG pregnancy test after embryotransfer; No embryo obtained after IVF; Positive HCG pregnancy test after embryotransfer

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• donors
• uterine abnormalities

Sponsors & Collaborators

• Calla IVF Center: lead

Study Sites (1)

Calla Ivf Center

Oradea, Bihor County, 410103, Romania

Location

MeSH Terms

Conditions

Teratozoospermia; Aneuploidy

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: January 30, 2025
• Study Start: October 21, 2023
• Primary Completion: October 23, 2024
• Study Completion: November 10, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

RO (1)