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Recruiting NCT06880302

Male Infertility and Assisted Reproductive Technologies Research Biobank

Observational Male Infertility Infertility (IVF Patients)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Male Infertility, Infertility (IVF Patients). Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART).

Detailed description

The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART). These specimens include testicular tissue, sperm, semen samples, donor sperm or discarded sperm preps. These samples were possibly utilized for diagnostic testing such as semen analyses or DNA fragmentation testing or for ART procedures such as intrauterine insemination (IUI) in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) and are no longer needed clinically. Rather than discarding those samples the men who provided them or the sperm recipient in the case of donor sperm may elect to donate them for future research purposes. These samples will be used for future research regarding male infertility and assisted reproductive technologies.

Primary outcome measures

  • Biobank [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Males providing testicular tissue, sperm, semen samples, discarded sperm preps for IUI/IVF/ICSI or the sperm recipient for those utilizing donor sperm, for cryopreservation at the respective site(s) for either clinical use or preservation

Exclusion criteria

  • Samples that are quarantined or in isolation dewars for infectious diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • RMANJ — Basking Ridge

Identifiers

NCT: NCT06880302 · RMA-2022-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗