OligospermiaPhase 2NCT07481370
Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm
A Phase 2 study testing isotretinoin and Human chorionic gonadotrophin (hCG) in people with Oligospermia and Azoospermia, Nonobstructive, run by University of Nebraska at 1 site in United States.
Trial summary
This study compares two medical treatments to see how well they improve sperm production in men with infertility due to low sperm counts (oligospermia) or no sperm in the semen due to non-obstructive causes (nonobstructive azoospermia). Read more about this study
- Who is it for?
- Ages 19 to 50 years, men only
- Conditions the study is for
- Oligospermia, Azoospermia, Nonobstructive, Infertility
- What is being tested?
- isotretinoin and Human chorionic gonadotrophin (hCG)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to 31 Dec 2027
- Phase
- Phase 2
- 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 19 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male participants aged 19 to 50 years
- Confirmed diagnosis of oligospermia (sperm concentration <15 million/mL), nonobstructive azoospermia, or hypogonadotropic hypogonadism (defined by low or normal FSH with low testosterone)
- Normal genetic evaluation if diagnosed with azoospermia
- No other identified and correctable cause of infertility
- Considered appropriate candidates for medical therapy for infertility in the clinical judgment of the investigators
- Willing and able to comply with study procedures, including laboratory testing, semen analyses, and follow-up visits
- Able to provide informed consent
Who cannot join
- Obstructive azoospermia (including vasal obstruction, ejaculatory duct obstruction, or prior vasectomy)
- Prior successful medical therapy for infertility
- Current or recent use of medications known to impair spermatogenesis, including exogenous testosterone or anabolic steroids, unless discontinued with adequate washout
- Current use of isotretinoin for any indication
- Contraindications to isotretinoin (including significant liver disease or uncontrolled hyperlipidemia)
- Contraindications to human chorionic gonadotropin (including hormone-sensitive malignancy)
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- Significant medical or psychiatric conditions that, in the opinion of the investigators, would interfere with safe participation
- Inability to provide semen samples
- Inability to provide informed consent
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
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Prospective Comparison of Isotretinoin and hCG Therapy in Males With Oligospermia and Azoospermia
This study compares two medical treatments to see how well they improve sperm production in men with infertility due to low sperm counts (oligospermia) or no sperm in the semen due to non-obstructive causes (nonobstructive azoospermia). Some men with these conditions have limited nonsurgical treatment options, and current therapies do not work for everyone.
Participants in this study will be adult men ages 19 to 50 who have been diagnosed with oligospermia or nonobstructive azoospermia and do not have a correctable cause for infertility. Eligible participants will be randomly assigned to receive one of two treatments for three months: oral isotretinoin taken twice daily, or human chorionic gonadotropin (hCG) injections given three times per week. hCG is a standard hormonal therapy used in certain types of male infertility, while isotretinoin is being studied for its potential role in stimulating sperm production.
Read more
At the start of the study, participants will have blood tests to measure reproductive hormone levels and a semen analysis. Blood tests will be repeated at one month and three months, and a repeat semen analysis will be performed at three months, which corresponds to a full cycle of sperm development. The main goal of the study is to determine whether motile (moving) sperm appear in the semen after treatment. Additional goals include measuring changes in sperm count and hormone levels, as well as monitoring medication side effects.
Both study medications are FDA-approved and have known side effect profiles. Participants may or may not experience improvement in sperm production. The results of this study may help guide future treatment options for men with infertility due to low or absent sperm production.
- Conditions
- Oligospermia, Azoospermia, Nonobstructive, Infertility
- Being tested
- isotretinoin, Human chorionic gonadotrophin (hCG)
- Medical subject headings
- Oligospermia, Azoospermia, Nonobstructive, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotretinoinDrug
Oral isotretinoin administered at a dose of 20 mg twice daily for 3 months as part of a randomized treatment arm evaluating effects on sperm production and reproductive hormone levels.
Human chorionic gonadotrophin (hCG)Drug
Human chorionic gonadotropin (hCG) administered by subcutaneous injection at a dose of 2,000 units three times weekly for 3 months as part of a randomized treatment arm evaluating effects on sperm production and reproductive hormone levels.
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin Treatment Arm | Experimental | Participants in this arm will receive oral isotretinoin 20 mg twice daily for 3 months. Reproductive hormone testing will be performed at baseline, 1 month, and 3 months, and a semen analysis will be repeated at 3 months to assess treatment response. Receives: Drug: isotretinoin |
| hCG Treatment Arm | Active comparator | Participants in this arm will receive human chorionic gonadotropin (hCG) injections at a dose of 2,000 units three times weekly for 3 months. Reproductive hormone testing will be performed at baseline, 1 month, and 3 months, and a semen analysis will be repeated at 3 months to assess treatment response Receives: Drug: Human chorionic gonadotrophin (hCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Motile Sperm in the Ejaculate
Assessment of whether motile (moving) sperm are present in the ejaculate following treatment with isotretinoin or human chorionic gonadotropin (hCG), as determined by standard semen analysis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start13 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligospermiaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Deibert, University of Nebraska
- Investigators
- Chris Deibert, MD, MPH, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481370
- Sponsor's protocol ID
- 0849-25-FB
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Isotretinoin and hCG Therapy in Males With Oligospermia and Azoospermia
- ClinicalTrials.gov ID
- NCT07481370
- Acronym / sponsor ID
- 0849-25-FB
- Conditions
- Oligospermia, Azoospermia, Nonobstructive, Infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2026 (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.
This study compares two medical treatments to see how well they improve sperm production in men with infertility due to low sperm counts (oligospermia) or no sperm in the semen due to non-obstructive causes (nonobstructive azoospermia). Some men with these conditions have limited nonsurgical treatment options, and current therapies do not work for everyone.
Participants in this study will be adult men ages 19 to 50 who have been diagnosed with oligospermia or nonobstructive azoospermia and do not have a correctable cause for infertility. Eligible participants will be randomly assigned to receive one of two treatments for three months: oral isotretinoin taken twice daily, or human chorionic gonadotropin (hCG) injections given three times per week. hCG is a standard hormonal therapy used in certain types of male infertility, while isotretinoin is being studied for its potential role in stimulating sperm production.
At the start of the study, participants will have blood tests to measure reproductive hormone levels and a semen analysis. Blood tests will be repeated at one month and three months, and a repeat semen analysis will be performed at three months, which corresponds to a full cycle of sperm development. The main goal of the study is to determine whether motile (moving) sperm appear in the semen after treatment. Additional goals include measuring changes in sperm count and hormone levels, as well as monitoring medication side effects.
Both study medications are FDA-approved and have known side effect profiles. Participants may or may not experience improvement in sperm production. The results of this study may help guide future treatment options for men with infertility due to low or absent sperm production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin Treatment Arm | Experimental | Drug: isotretinoinParticipants in this arm will receive oral isotretinoin 20 mg twice daily for 3 months. Reproductive hormone testing will be performed at baseline, 1 month, and 3 months, and a semen analysis will be repeated at 3 months to assess treatment response. |
| hCG Treatment Arm | Active comparator | Drug: Human chorionic gonadotrophin (hCG)Participants in this arm will receive human chorionic gonadotropin (hCG) injections at a dose of 2,000 units three times weekly for 3 months. Reproductive hormone testing will be performed at baseline, 1 month, and 3 months, and a semen analysis will be repeated at 3 months to assess treatment response |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male participants aged 19 to 50 years
- Confirmed diagnosis of oligospermia (sperm concentration <15 million/mL), nonobstructive azoospermia, or hypogonadotropic hypogonadism (defined by low or normal FSH with low testosterone)
- Normal genetic evaluation if diagnosed with azoospermia
- No other identified and correctable cause of infertility
- Considered appropriate candidates for medical therapy for infertility in the clinical judgment of the investigators
Key exclusion criteria (9 listed)
- Obstructive azoospermia (including vasal obstruction, ejaculatory duct obstruction, or prior vasectomy)
- Prior successful medical therapy for infertility
- Current or recent use of medications known to impair spermatogenesis, including exogenous testosterone or anabolic steroids, unless discontinued with adequate washout
- Current use of isotretinoin for any indication
- Contraindications to isotretinoin (including significant liver disease or uncontrolled hyperlipidemia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isotretinoinOral isotretinoin administered at a dose of 20 mg twice daily for 3 months as part of a randomized treatment arm evaluating effects on sperm production and reproductive hormone levels. | Drug | Isotretinoin Treatment Arm |
| Human chorionic gonadotrophin (hCG)Human chorionic gonadotropin (hCG) administered by subcutaneous injection at a dose of 2,000 units three times weekly for 3 months as part of a randomized treatment arm evaluating effects on sperm production and reproductive hormone levels. | Drug | hCG Treatment Arm |
Primary outcome
Presence of Motile Sperm in the Ejaculate
Time frame: 3 months
Assessment of whether motile (moving) sperm are present in the ejaculate following treatment with isotretinoin or human chorionic gonadotropin (hCG), as determined by standard semen analysis
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 20 Apr 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.
Chris Deibert, MD, MPH principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing isotretinoin and Human chorionic gonadotrophin (hCG) in people with Oligospermia and Azoospermia, Nonobstructive, run by University of Nebraska 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 7 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: enrolling by invitation, as of the sponsor's last update on 20 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Presence of Motile Sperm in the Ejaculate (time frame: 3 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 20 Apr 2026.