Male Infertility and Assisted Reproductive Technologies Research Biobank

Recruiting

• Conditions: Male Infertility; Infertility (IVF Patients)

• Registration Number: NCT06880302
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-04
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2032-04
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biobank	5 years	The purpose of this study is to create a biobank of male biological specimens

Trial Locations

Locations (1)

RMANJ; 🇺🇸 Basking Ridge, New Jersey, United States