Male InfertilityNCT02864329
Small RNA Pathways in Mammalian Gametogenesis
An observational study of Male Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Basic and clinical research is revealing that various noncoding and small RNAs play important and diverse roles in germ cell development and quality, including X/Y silencing during meiosis, gene regulation, DNA damage responses, and protection of the genome against transposable elements. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Male Infertility
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 20 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men between the age of 18 and 90 who have testicular cancer and underwent surgery for removal at Weill Cornell Medicine.
Who may be able to join
- Men between the ages of 18-90 who have testicular cancer and underwent surgery at Weill Cornell Medicine.
Who cannot join
- Women, men outside of the age parameters
Trial locations and contacts
1 site in 1 country.
About this study
Basic and clinical research is revealing that various noncoding and small RNAs play important and diverse roles in germ cell development and quality, including X/Y silencing during meiosis, gene regulation, DNA damage responses, and protection of the genome against transposable elements. Indeed, mammalian germ cells are known to harbor multiple small RNA species, including small interfering RNAs (siRNA), microRNAs (miRNA), and germline- specific PIWI- interacting RNAs (piRNA). However, their mechanistic roles in gametogenesis and human infertility are largely uncharacterized. The goal of this study is to elucidate the role of small RNA pathways in the events that give rise to viable euploid gametes. Four projects and three cores are included in this study.
Read the detailed description
Project 2 (PI: Dr. Darius Paduch): Role of Small RNAs in male infertility. The leading hypothesis of this project is based on extensive preliminary results obtained by this group showing that 70% of miRNA expressed from human testis are highly conserved in humans and rodents. The investigators hypothesize that differentially expressed miRNAs in men with infertility lead to changes in levels of target messenger RNAs (mRNAs) involved in key regulatory pathways in cell biology. The results of this project will lead to better understanding of miRNAs' role in male reproduction and have strong potential to enable the development of new miRNA-based or miRNA-regulating therapies. This project will help to develop new transgenic animals to study miRNA in vivo with implications not only for infertility, but also biology of testicular cancer. Derived RNA based therapies have the potential to be less invasive, less toxic, and more effective in treating these serious and increasingly prevalent conditions.
Core A (PI: Dr. Paula E. Cohen): Administration Core. The main objective of the Administrative Core (Core A) is to provide a structure and support mechanism to the entire Center for Reproductive Genomics (CRG). The Admin core will facilitate interactions across the Ithaca and Manhattan campuses of Cornell University, will encourage research in small RNA biology, both in reproductive medicine and across clinical disciplines, and will promote strong training in reproductive medicine that encourages a translational focus. In general, the Admin core will focus efforts on three major philosophies: translational and innovative research, teaching, and outreach.
Core B (PI: Dr. Andrew Grimson): RNA Sequencing Core. The main objective of the RNA Sequencing Core (RSC) is to provide users with efficient and high quality access to cutting-edge sequencing technologies. These sequencing technologies will be used by all members of this P50-proposal, and made available to other P50-centers. Importantly, all members of this P50 are relying on access to these technologies to achieve their project goals. By centralizing sequencing at the RSC, sequencing will be performed at a lower cost and with greater efficiency that would be possible for individual users.
Core C (PI: Dr. Peter Schlegel): Outreach Core The goals of this outreach core are two-fold: (1) to provide a scientific and technical resource for clinicians interested in embarking on research involving small RNA biology in their physiological system of interest, and (2) to provide outreach to the community by means of a state- of-the-art lecture series. The Innovation Seminars in Reproductive Technologies Series (InSeRT), in order to educate patients about the latest advances in our understanding of the genetic and epigenetic basis for human disease.
- Conditions
- Male Infertility
- Keywords
- Male Infertility, micro RNAs, small interfering RNAs, miRNA, siRNA
- Medical subject headings
- Infertility, Male
What is being measured
The primary outcome is the main question the study is designed to answer.
Using RNA from men with normal spermatogenesis and men with infertility for multiplexed deep sequencing to identify differentially expressed miRNAs
Detect target mRNAs through correlation analysis of actual mRNA expression profiles obtained from the same patients. At the end of the proposed funding period, project 2 will have identified and confirmed a set of approximately 20-30 miRNA:mRNA interactions in male infertility.
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 posted12 Aug 2016 (estimated)
- Study startApr 2014
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
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.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Peter N Schlegel, M.D., Principal investigator, Weill Medical College of Cornell UniversityPaula E. Cohen, Ph.D., Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864329
- Sponsor's protocol ID
- 1209013034
- Other IDs
- 5P50HD076210
- Status last verified
- Jul 2024
- First submitted
- 26 Apr 2016
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small RNA Pathways in Mammalian Gametogenesis
- ClinicalTrials.gov ID
- NCT02864329
- Acronym / sponsor ID
- 1209013034
- Conditions
- Male Infertility
- Keywords
- Male Infertility, micro RNAs, small interfering RNAs, miRNA, siRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Cornell University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2014
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 12 Aug 2016 (estimated)
- 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.
Basic and clinical research is revealing that various noncoding and small RNAs play important and diverse roles in germ cell development and quality, including X/Y silencing during meiosis, gene regulation, DNA damage responses, and protection of the genome against transposable elements. Indeed, mammalian germ cells are known to harbor multiple small RNA species, including small interfering RNAs (siRNA), microRNAs (miRNA), and germline- specific PIWI- interacting RNAs (piRNA). However, their mechanistic roles in gametogenesis and human infertility are largely uncharacterized. The goal of this study is to elucidate the role of small RNA pathways in the events that give rise to viable euploid gametes. Four projects and three cores are included in this study.
Detailed description
Project 2 (PI: Dr. Darius Paduch): Role of Small RNAs in male infertility. The leading hypothesis of this project is based on extensive preliminary results obtained by this group showing that 70% of miRNA expressed from human testis are highly conserved in humans and rodents. The investigators hypothesize that differentially expressed miRNAs in men with infertility lead to changes in levels of target messenger RNAs (mRNAs) involved in key regulatory pathways in cell biology. The results of this project will lead to better understanding of miRNAs' role in male reproduction and have strong potential to enable the development of new miRNA-based or miRNA-regulating therapies. This project will help to develop new transgenic animals to study miRNA in vivo with implications not only for infertility, but also biology of testicular cancer. Derived RNA based therapies have the potential to be less invasive, less toxic, and more effective in treating these serious and increasingly prevalent conditions.
Core A (PI: Dr. Paula E. Cohen): Administration Core. The main objective of the Administrative Core (Core A) is to provide a structure and support mechanism to the entire Center for Reproductive Genomics (CRG). The Admin core will facilitate interactions across the Ithaca and Manhattan campuses of Cornell University, will encourage research in small RNA biology, both in reproductive medicine and across clinical disciplines, and will promote strong training in reproductive medicine that encourages a translational focus. In general, the Admin core will focus efforts on three major philosophies: translational and innovative research, teaching, and outreach.
Core B (PI: Dr. Andrew Grimson): RNA Sequencing Core. The main objective of the RNA Sequencing Core (RSC) is to provide users with efficient and high quality access to cutting-edge sequencing technologies. These sequencing technologies will be used by all members of this P50-proposal, and made available to other P50-centers. Importantly, all members of this P50 are relying on access to these technologies to achieve their project goals. By centralizing sequencing at the RSC, sequencing will be performed at a lower cost and with greater efficiency that would be possible for individual users.
Core C (PI: Dr. Peter Schlegel): Outreach Core The goals of this outreach core are two-fold: (1) to provide a scientific and technical resource for clinicians interested in embarking on research involving small RNA biology in their physiological system of interest, and (2) to provide outreach to the community by means of a state- of-the-art lecture series. The Innovation Seminars in Reproductive Technologies Series (InSeRT), in order to educate patients about the latest advances in our understanding of the genetic and epigenetic basis for human disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men between the age of 18 and 90 who have testicular cancer and underwent surgery for removal at Weill Cornell Medicine.
Key inclusion criteria (1 listed)
- Men between the ages of 18-90 who have testicular cancer and underwent surgery at Weill Cornell Medicine.
Key exclusion criteria (1 listed)
- Women, men outside of the age parameters
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
Using RNA from men with normal spermatogenesis and men with infertility for multiplexed deep sequencing to identify differentially expressed miRNAs
Time frame: 5 years
Detect target mRNAs through correlation analysis of actual mRNA expression profiles obtained from the same patients. At the end of the proposed funding period, project 2 will have identified and confirmed a set of approximately 20-30 miRNA:mRNA interactions in male infertility.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- 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. This study is not recruiting at the moment.
Peter N Schlegel, M.D. principal investigator
Weill Medical College of Cornell University
Paula E. Cohen, Ph.D. principal investigator
Cornell University
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, run by Weill Medical College of Cornell University 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: finished, as of the sponsor's last update on 19 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using RNA from men with normal spermatogenesis and men with infertility for multiplexed deep sequencing to identify differentially expressed miRNAs (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 19 Jul 2024.