Male Infertility Due to AzoospermiaROSINCT04053309
Round Spermatid Injection Protocol
An observational study of Male Infertility Due to Azoospermia, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
To evaluate embryology outcomes after application of a technique known as round spermatid injection (ROSI) into donor oocytes in a high-volume clinical infertility practice. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male Infertility Due to Azoospermia
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2019to 8 Jan 2021
- 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 years and older
- Men only
- Adult, Older adult
Study population: At least 10 healthy oocyte donors and at least 10 male patients with a diagnosis of male factor infertility (undergoing TESE or microTESE) to participate in this study. All male patients undergoing surgical sperm extraction (TESE or microTESE) procedures as part of an IVF cycle at our center will be reviewed for inclusion and offered participation in the study. These men have been previously consented to the TESE or microTESE procedure at our center. The study will utilize the otherwise discarded round spermatids found in the TESE and microTESE surgical samples as the study samples being used for the ROSI procedure.
Major Inclusion Criteria: The following are major inclusion criteria:
- A diagnosis of azoospermia after semen analysis.
- Indication to proceed with testicular sperm extraction (TESE or microTESE) based on a urologic evaluation.
- Presence of round spermatids from testicular sperm extraction (TESE or microTESE), irrespective of the presence or absence of mature spermatozoa.
Major Exclusion Criteria (must not meet any): The following are exclusion criteria:
- Under 18 years old
- All patients who do not voluntarily give their written consent for participation.
- Men who do not wish to use their gametes (round spermatids) for fertilization of donor oocytes for research purposes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Assoicates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
Official title: Implementation of a Round Spermatid Injection Protocol in a Clinical Infertility Practice
To evaluate embryology outcomes after application of a technique known as round spermatid injection (ROSI) into donor oocytes in a high-volume clinical infertility practice.
Read the detailed description
The objective of this study is to assess embryology outcomes after implementation of a laboratory protocol known as ROSI at a high-volume clinical infertility practice. All samples from enrolled male patients with azoospermia who proceed with surgical sperm extraction (TESE or microTESE) will be evaluated for the presence of round spermatids. These round spermatids will be used as research samples as opposed to being discarded.
The investigators aim to identify whether the injection of round spermatids into donor oocytes can lead to successful fertilization, progression to the blastocyst stage, and euploid status. Performance of ROSI using donor oocytes not intended for implantation will allow the investigators to gain valuable insight regarding fertilization and development without any direct risk to patients or future offspring. These embryos are being generated for research purposes only and will ultimately be destroyed after the study has concluded. The investigators will measure rates of isolation of round spermatids from surgical samples, fertilization rates using donor oocytes, rates of progression to the blastocyst stage, and rates of aneuploidy using the previously described technique of ROSI.
- Conditions
- Male Infertility Due to Azoospermia
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 undergoing TESE or microTESE | All male patients undergoing surgical sperm extraction (TESE or microTESE) procedures as part of an IVF cycle at our center will be reviewed for inclusion and offered participation in the study. These men have been previously consented to the TESE or microTESE procedure at our center. The study will utilize the otherwise discarded round spermatids found in the TESE and microTESE surgical samples as the study samples being used for the ROSI procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euploid blastulation rate
number of fertilized eggs progressing to the blastocyst stage of development which are euploid
Measured: 1-2 weeks
Secondary outcomes (4)
Fertilization Rate
Number of mature eggs fertilized by round spermatids
Measured: 1 day post intracytoplasmic sperm injection procedure
Prevalence of round spermatids in surgical sperm samples
the number of round spermatids present after a TESE or microTESE procedure is performed
Measured: immediately after the TESE or microTESE
Overall blastulation rate
number of fertilized eggs progressing to the blastocyst stage of development
Measured: 1 week
Aneuploidy rate
the number of abnormal embryos after PGT-A
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start16 Aug 2019
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Infertility Due to AzoospermiaStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Hanson, MD, Study director, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053309
- Sponsor's protocol ID
- RMA-2019-03
- Acronym
- ROSI
- Status last verified
- May 2021
- First submitted
- 9 Aug 2019
- Last updated
- 19 May 2021
- 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 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Round Spermatid Injection Protocol in a Clinical Infertility Practice
- ClinicalTrials.gov ID
- NCT04053309
- Acronym / sponsor ID
- ROSI / RMA-2019-03
- Conditions
- Male Infertility Due to Azoospermia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 12 Aug 2019 (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.
To evaluate embryology outcomes after application of a technique known as round spermatid injection (ROSI) into donor oocytes in a high-volume clinical infertility practice.
Detailed description
The objective of this study is to assess embryology outcomes after implementation of a laboratory protocol known as ROSI at a high-volume clinical infertility practice. All samples from enrolled male patients with azoospermia who proceed with surgical sperm extraction (TESE or microTESE) will be evaluated for the presence of round spermatids. These round spermatids will be used as research samples as opposed to being discarded.
The investigators aim to identify whether the injection of round spermatids into donor oocytes can lead to successful fertilization, progression to the blastocyst stage, and euploid status. Performance of ROSI using donor oocytes not intended for implantation will allow the investigators to gain valuable insight regarding fertilization and development without any direct risk to patients or future offspring. These embryos are being generated for research purposes only and will ultimately be destroyed after the study has concluded. The investigators will measure rates of isolation of round spermatids from surgical samples, fertilization rates using donor oocytes, rates of progression to the blastocyst stage, and rates of aneuploidy using the previously described technique of ROSI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males undergoing TESE or microTESE | – | –All male patients undergoing surgical sperm extraction (TESE or microTESE) procedures as part of an IVF cycle at our center will be reviewed for inclusion and offered participation in the study. These men have been previously consented to the TESE or microTESE procedure at our center. The study will utilize the otherwise discarded round spermatids found in the TESE and microTESE surgical samples as the study samples being used for the ROSI procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- At least 10 healthy oocyte donors and at least 10 male patients with a diagnosis of male factor infertility (undergoing TESE or microTESE) to participate in this study. All male patients undergoing surgical sperm extraction (TESE or microTESE) procedures as part of an IVF cycle at our center will be reviewed for inclusion and offered participation in the study. These men have been previously consented to the TESE or microTESE procedure at our center. The study will utilize the otherwise discarded round spermatids found in the TESE and microTESE surgical samples as the study samples being used for the ROSI procedure.
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
Euploid blastulation rate
Time frame: 1-2 weeks
number of fertilized eggs progressing to the blastocyst stage of development which are euploid
4 secondary outcomes
Fertilization Rate
Time frame: 1 day post intracytoplasmic sperm injection procedure
Prevalence of round spermatids in surgical sperm samples
Time frame: immediately after the TESE or microTESE
Overall blastulation rate
Time frame: 1 week
Aneuploidy rate
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- 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.
Brent Hanson, MD study director
Reproductive Medicine Associates of New Jersey
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 Due to Azoospermia, 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?
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: stopped early, as of the sponsor's last update on 19 May 2021. 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 was stopped early (reason given: low enrollment). Results are not available in the source record.
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?
Euploid blastulation rate (time frame: 1-2 weeks). 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 May 2021.