Male InfertilitySPOTNCT05966883
SpermQT Prospective Observational Trial
An observational study of Male Infertility, run by Inherent Biosciences at 6 sites in United States.
Trial summary
The goal of the study is to validate the ability of the Epigenetic Sperm Quality Test (SpermQT) to assess a man's sperm quality and corresponding success of infertility treatments. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Male Infertility
- How many people
- 1,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jan 2023to 30 Sep 2026
- 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 18 to 45 years
- All sexes
- Adult
Study population: Couples that are eligible for an IUI procedure and/or have been recommended to pursue IUI, and/or couples have recently completed an IUI cycle (no matter the outcome)
Who may be able to join
- The subjects have been recommended to pursue IUI, or they have recently completed an IUI (regardless of outcome)
- Male partner is under 45 years of age
- Female partner is under 38 years of age
- The total motile sperm count from the raw semen analysis must be greater than or equal to 10 million
Who cannot join
- The female or male partner have a BMI equal to or greater than 40
- The male partner has undergone male testosterone replacement therapy in the last 6 months
- Either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses
- There are any known factors contributing to female factor infertility, such as but not limited to:
- Severe Endometriosis (stage 3 or higher, endometrioma on ovaries)
- Multiple uterine fibroids 5cm or larger
Show all 9Show fewer
- Severe Asherman's Syndrome
- Severe Mullerian anomaly
- Lack of tubal patency in at least one fallopian tubes
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Shady Grove Fertility
Greenwood Village, Colorado, 80111
Inception Fertility, LLC
Houston, Texas, 77081
Yale Medicine
Orange, Connecticut, 06477
Male Fertility and Sexual Medicine Specialists
San Diego, California, 92120
University of Washington
Seattle, Washington, 98105
Boston IVF
Waltham, Massachusetts, 02451
About this study
The goal of the study is to validate the ability of the Epigenetic Sperm Quality Test (SpermQT) to assess a man's sperm quality and corresponding success of infertility treatments.
Read the detailed description
This prospective study will consist of analyzing a man's semen sample to determine the patient's SpermQT score and following the success of each fertility treatment to produce a pregnancy and live birth. Physicians and patients will be blinded to SpermQT results.
- Conditions
- Male Infertility
- Keywords
- Epigenetics
- Medical subject headings
- Infertility, Male
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)
Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of IUI in each bracket of SpermQT score (Poor, Normal, and Excellent)
Measured: 6 months
Secondary outcomes (2)
Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF)
Number of patients that have and have not achieved pregnancy during subsequent rounds of IUI and with IVF in each bracket of SpermQT score (Poor, Normal, and Excellent)
Measured: 18 months
Number of patients that have and have not achieved a live birth
Number of patients that have and have not achieved a live birth in each bracket of SpermQT score (Poor, Normal, and Excellent)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jan 2023
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Sep 2026 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inherent Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University, Boston IVF, Shady Grove Fertility, University of Washington, Brigham Young University, Male Fertility and Sexual Medicine Specialists, Inception Fertility Research Institute, LLC
- Responsible party
- Sponsor
- Investigators
- Kristin Brogaard, PhD, Principal investigator, Inherent Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966883
- Sponsor's protocol ID
- SPOT001
- Acronym
- SPOT
- Status last verified
- Mar 2026
- First submitted
- 30 May 2023
- Last updated
- 12 Mar 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpermQT Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT05966883
- Acronym / sponsor ID
- SPOT / SPOT001
- Conditions
- Male Infertility
- Keywords
- Epigenetics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Inherent BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Yale University, Boston IVF, Shady Grove Fertility, University of Washington, Brigham Young University, Male Fertility and Sexual Medicine Specialists, Inception Fertility Research Institute, LLC
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Aug 2023 (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 goal of the study is to validate the ability of the Epigenetic Sperm Quality Test (SpermQT) to assess a man's sperm quality and corresponding success of infertility treatments.
Detailed description
This prospective study will consist of analyzing a man's semen sample to determine the patient's SpermQT score and following the success of each fertility treatment to produce a pregnancy and live birth. Physicians and patients will be blinded to SpermQT results.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Couples that are eligible for an IUI procedure and/or have been recommended to pursue IUI, and/or couples have recently completed an IUI cycle (no matter the outcome)
Key inclusion criteria (4 listed)
- The subjects have been recommended to pursue IUI, or they have recently completed an IUI (regardless of outcome)
- Male partner is under 45 years of age
- Female partner is under 38 years of age
- The total motile sperm count from the raw semen analysis must be greater than or equal to 10 million
Key exclusion criteria (9 listed)
- The female or male partner have a BMI equal to or greater than 40
- The male partner has undergone male testosterone replacement therapy in the last 6 months
- Either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses
- There are any known factors contributing to female factor infertility, such as but not limited to:
- Severe Endometriosis (stage 3 or higher, endometrioma on ovaries)
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
Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)
Time frame: 6 months
Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of IUI in each bracket of SpermQT score (Poor, Normal, and Excellent)
2 secondary outcomes
Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF)
Time frame: 18 months
Number of patients that have and have not achieved a live birth
Time frame: 18 months
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 12 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Male Infertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Active, not recruitingPhase 1/2
A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
Infertility Due to Azoospermia, Infertility, Male
Active, not recruiting
YO® Smartphone Home Sperm Test Versus Manual Semen Analysis in Egyptian Men
Semen Analysis, Male Infertility
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Not yet recruitingPhase 4
Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
Oligoasthenoteratozoospermia, Male Infertility
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.
Kristin Brogaard, PhD principal investigator
Inherent Biosciences
6 sites 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 Inherent Biosciences at 6 sites 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI) (time frame: 6 months). 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 12 Mar 2026.