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

NCT ID: NCT06801652

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-21

Study Completion Date

2024-11-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spermatozoa, Abnormal in Vitro Fertilization Blastocyst Aneuploidy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Sperm morphology indexes

Intervention Type OTHER

We analyzed all sperm morphology indexes in all groups.

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.

Sperm morphology indexes

Intervention Type OTHER

We analyzed all sperm morphology indexes in all groups.

No embryo obtained after IVF

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

Sperm morphology indexes

Intervention Type OTHER

We analyzed all sperm morphology indexes in all groups.

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.

Sperm morphology indexes

Intervention Type OTHER

We analyzed all sperm morphology indexes in all groups.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sperm morphology indexes

We analyzed all sperm morphology indexes in all groups.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* donors
* uterine abnormalities
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Calla IVF Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Calla Ivf Center

Oradea, Bihor County, Romania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Romania

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CALLA TERATOZOOSPERMIA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Use of IMSI in Poor Responders to IVF
NCT02358733 TERMINATED NA