NCT04795440

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

March 8, 2021

Last Update Submit

March 11, 2025

Conditions

OligospermiaDNA DamageIVFICSIEmbryo

Keywords

ICSISperm DNA fragmentationOligospermiaTesticular sperm

Outcome Measures

Primary Outcomes (1)

  • Euploid embryo rate

    Number of chromosomally normal embryos divided by the number of embryos biopsied in each group.

    4 weeks

Secondary Outcomes (3)

  • SDF rate

    1 week

  • Sperm aneuploidy rate

    3 weeks

  • Good-quality embryo rate

    4 weeks

Other Outcomes (5)

  • Clinical Pregnancy rate

    up to 9 months

  • Implantation rate

    up to 9 months

  • Miscarriage rate

    up to 9 months

  • +2 more other outcomes

Study Arms (2)

Eya-ICSI

NO INTERVENTION

Oocytes inseminated by ICSI technique with spermatozoa from the ejaculate (control group).

Test-ICSI

EXPERIMENTAL

Oocytes inseminated by ICSI technique with spermatozoa from the testicle (study group).

Procedure: Testicular biopsy

Interventions

Testicular biopsyPROCEDURE

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

Test-ICSI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Infertile males with severe oligospermia (\<5 mill/ml of spermatozoa in the ejaculate) or infertile males without severe oligospermia (\>5 mill/ml of spermatozoa in the ejaculate) but with a previous complete ICSI failure. In addition, all of them have to have a sperm DNA fragmentation test level higher than 30% (SDF\>30%), the threshold value for considering the result as abnormal.
  • Women with adequate ovarian reserve, understood as those with AMH values \>10pM, and Antral Follicular Count (AFC) \>10.

You may not qualify if:

  • Abnormal karyotype (previously known).
  • Microdeletions in the Y chromosome (previously known).
  • Carriers of known cystic fibrosis gene mutations.
  • Presence of varicocele.
  • Female age \>38 years.
  • Presence of uterine pathology that may condition reproductive outcomes (fibroids, uterine malformations).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Foundation

Valencia, Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Oligospermia

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Irene Hervás Herrero, MSc

    IVI Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The oocytes will be randomly assigned to one of the two study groups, and only the person who microinjects them will know which group each oocyte belongs to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective and interventional
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 12, 2021

Study Start

October 1, 2020

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

ES(1)