Male Infertility and Assisted Reproductive Technologies Research Biobank

NCT ID: NCT06880302

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-04

Study Completion Date

2032-12-31

Brief Summary

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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

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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.

Conditions

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Male Infertility Infertility (IVF Patients)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Males providing specimen for infertility treatment

Males providing specimen for infertility treatment

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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RMANJ

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Caroline Zuckerman, RN BSN

Role: CONTACT

9736562841

Christine Whitehead, MS, BSN, RN

Role: CONTACT

9736562841

Facility Contacts

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Caroline Zuckerman, BS BSN RN

Role: primary

9736562841

Other Identifiers

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RMA-2022-01

Identifier Type: -

Identifier Source: org_study_id

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