Male InfertilityMARKNCT06880302
Male Infertility and Assisted Reproductive Technologies Research Biobank
An observational study of Male Infertility and Infertility (IVF Patients), run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Male Infertility, Infertility (IVF Patients)
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males that had previously provided male biological specimen for their infertility treatment that no longer wishes to keep their samples frozen
Who may be able to join
- 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
Who cannot join
- Samples that are quarantined or in isolation dewars for infectious diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
RMANJ
Basking Ridge, New Jersey, 07920
Caroline Zuckerman, BS BSN RN, 9736562841, clinicalresearchteam@ivirma.com
About this study
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).
Read the 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.
- Conditions
- Male Infertility, Infertility (IVF Patients)
- Medical subject headings
- Infertility, Male, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Males providing specimen for infertility treatment | Males providing specimen for infertility treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biobank
The purpose of this study is to create a biobank of male biological specimens
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start4 Mar 2025
- Primary completionApr 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880302
- Sponsor's protocol ID
- RMA-2022-01
- Acronym
- MARK
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Infertility and Assisted Reproductive Technologies Research Biobank
- ClinicalTrials.gov ID
- NCT06880302
- Acronym / sponsor ID
- MARK / RMA-2022-01
- Conditions
- Male Infertility, Infertility (IVF Patients)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males providing specimen for infertility treatment | – | –Males providing specimen for infertility treatment |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males that had previously provided male biological specimen for their infertility treatment that no longer wishes to keep their samples frozen
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Samples that are quarantined or in isolation dewars for infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biobank
Time frame: 5 years
The purpose of this study is to create a biobank of male biological specimens
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility and Infertility (IVF Patients), run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Zuckerman, RN BSN (9736562841, clinicalresearchteam@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biobank (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.