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Comparison of ICSI Outcomes in Cycles Using Testicular and Ejaculate Sperm From Couples With High SDF

NCT04795440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-03-13

No results posted yet for this study

Summary

In patients with oligospermia in the ejaculate or previous ICSI failures if it concurs with high DNA fragmentation, it has been hypothesized that the use of sperm obtained from the testicle would improve the clinical results, since a source of damage to the spermatic DNA is post-testicular in its storage in the epididymis and thus could be avoided. The clinical information available so far is low, of low quality and all the studies present certain limitations susceptible to improvements in further investigations before giving a definitive answer to patients in these circumstances, about whether they should opt for testicular biopsy or for the use of semen in the ejaculate.The intention proposed in our project, is to demonstrate whether using testicular sperm, compared to those available in an ejaculate in these cases, offers a clinically and statistically significant increase in chromosomally normal embryos available that may lead to better reproductive performance of the cycles, in a design never before done, where half of a patient's oocytes are inseminated from ejaculated sperm and the other half from sperm obtained in the testicular biopsy.

Conditions

  • Oligospermia
  • DNA Damage
  • IVF
  • ICSI
  • Embryo

Interventions

PROCEDURE

Testicular biopsy

Performance of a testicular biopsy with the intention of obtaining spermatozoa for the insemination of oocytes with the ICSI technique.

Sponsors & Collaborators

  • Fundación IVI

    lead OTHER

Principal Investigators

  • Irene Hervás Herrero, MSc · IVI Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-10-30
Completion
2023-10-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795440 on ClinicalTrials.gov