NCT06880302

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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
77mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Mar 2025Dec 2032

Study Start

First participant enrolled

March 4, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2032

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

June 2, 2026

Status Verified

June 1, 2026

Enrollment Period

7.1 years

First QC Date

March 11, 2025

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Biobank

    The purpose of this study is to create a biobank of male biological specimens

    5 years

Study Arms (1)

Males providing specimen for infertility treatment

Males providing specimen for infertility treatment

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males that had previously provided male biological specimen for their infertility treatment that no longer wishes to keep their samples frozen

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RMANJ

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Specimens include testicular tissue, sperm, semen samples, donor sperm or discarded sperm preps. Buccal swabs will also be collected if participants decide to participate in sub-study

MeSH Terms

Conditions

Infertility, MaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Caroline Zuckerman, RN BSN

CONTACT

Christine Whitehead, MS, BSN, RN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

March 4, 2025

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

June 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations